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Study matches: 20

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.


Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

This study is seeking children and young adults up to the age of 21 who have previously beaten childhood cancer. The study aims to identify individuals at greater risk to develop complications arising from their cancer treatment.
Jamie Walski -wals0183@umn.edu
All
up to 21 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• ELIGIBILITY CRITERIA
•CASES
• Diagnosis of primary cancer at age 21 or younger, irrespective of current age
• No prior history of allogeneic (non-autologous) hematopoietic cell transplant
• Development of one of the following key adverse events at any time following initiation of cancer therapy:
• Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
• Ischemic stroke (IS)
• Subsequent malignant neoplasm (SMN)
• Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
• Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
• Written informed consent from the patient and/or the patient?s legally authorized guardian
• In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
• ELIGIBILITY CRITERIA
•CONTROLS
• CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
• CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
• CONTROLS: No clinical evidence of any of the following key adverse events:
• Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
• Myocardial infarction (MI)
• Ischemic stroke (IS)
• Avascular necrosis (AVN)
• Subsequent malignant neoplasm (SMN)
• CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements
• CONTROLS: Written informed consent from the patient and/or the patient?s legally authorized guardian
• CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
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NCT00082745
Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration
Cancer Survivor; Cardiovascular Complication; Childhood Malignant Neoplasm
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Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study (VPA)

John Bass -bassx001@umn.edu
All
Not specified
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following: 1. Large volume left to right shunt (Qp/Qs >2:1), 2. Pulmonary hypertension (PA pressure >50% systemic) and/or 3. Clinical symptoms of congestive heart failure 4. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted. 2. Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions: 1. Left ventriculotomy or an extensive right ventriculotomy, 2. Failed previous VSD closure, 3. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or 4. Posterior apical VSDs covered by trabeculae. 5. Overall medical condition 3. Subject/legally authorized representative has signed the informed consent 4. Subject/legally authorized representative is willing to complete the follow-up requirements of this study
Exclusion Criteria:
1. Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid) 2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease 3. Subjects with perimembranous (close to the aortic valve) VSD 4. Subjects with post-infarction VSD 5. Subjects who weigh < 5.2 kg 6. Subjects with sepsis (local/generalized) 7. Subjects with active bacterial infections 8. Subjects with contraindications to anti-platelets
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NCT00647387
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
muscular; ventricular; septal; defects; VSD
Ventricular Septal Defects
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SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support? (SUSTAIN-IT)

Lauren Huffman -huffm052@umn.edu
All
60 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
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Patient
Inclusion Criteria:
1. Advanced HF and listed with the United Network for Organ Sharing (UNOS) for a "primary" HT or scheduled to receive a "primary" DT LVAD; 2. Ages 60-80 years and able to speak, read, and understand English; 3. Willing to participate and ability to provide informed consent. Caregiver Inclusion criteria: 1. Primary caregiver, identified by the patient, prior to DT MCS or while a candidate for HT; 2. Unpaid family member or friend who helps the patient with self-care; 3. Age > 21 years and able to speak, read, and write English; 4. Willing to participate and ability to provide informed consent. Patient Exclusion criteria 1. Patient has a prior HT or MCS device 2. Patient is listed for multiple organ transplantation (i.e., heart/lung, heart/kidney, etc.) Caregiver Exclusion criterion: 1) Patient refusal to participate.
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NCT02568930
quality of life heart failure mechanical support transplant
Heart Failure
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Spinal Cord Stimulation to Treat Hypertension

This study is looking for men and post-menopausal women over 40 years old who have high blood pressure. This study is trying to figure out how high blood pressure during exercise on a bike can be reduced using nerve stimulation.
Dan Chantigian -chant047@umn.edu
Manda Keller_Ross, PhD, DPT -kell0529@umn.edu
All
40 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Men and post-menopausal women between the ages of 40-90 years old 2. Hypertension (defined as BP ¿ 140/90), diagnosed by a physician 3. Ability of the patient to provide consent
Exclusion Criteria:
1. History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire. 2. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision) 3. Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation. Please contact study staff for information regarding your eligibility. 4. History of spinal fusion or laminectomy at L3 or above 5. Current prescription opioid usage 6. Contraindication to MRI 7. At physician discretion which will be documented on the case report form.
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NCT02828436
Device: Precision Spectra System; Behavioral: Exercise Intervention
Hypertension; High Blood Pressure
Hypertension
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Community Walking Exercise for Patients With Peripheral Artery Disease (GAIT)

Neeta Adhikari -adhik001@umn.edu
All
40 Years and over
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Men and women diagnosed with atherosclerotic PAD
• ¿40 years of age
• An abnormal ankle-brachial index (ABI) of ¿.90
• For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
• Patients receiving lower extremity ET or peripheral open intervention
• Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI
Exclusion Criteria:

• Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill
• Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
• PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
• Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
• Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
• Individuals who are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute
• Individuals who have had a myocardial infarction within 3 months prior to screening
• Individuals who demonstrate symptoms consistent with acute coronary syndrome
• Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ¿0.5 mm at rest and >1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ¿1 mm)
• Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
• Individuals with left bundle branch block or sustained ventricular tachycardia (>30 sec) during screening
• Individuals with uncontrolled hypertension (¿180 systolic or ¿100 diastolic resting blood pressure) during screening
• Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening; Patients can be reconsidered for study inclusion following a 1 month washout period from these medications
• Electrolyte abnormalities (e.g., potassium <3.3 mmol¿L¿1 )
• Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening)
• Incarcerated individuals
• Individuals acutely impaired by alcohol or other illicit drugs
• Poorly controlled diabetes defined as glycated hemoglobin >12%
• Severely anemic patients (Hgb <11 g¿dL¿1 for women and <10 g¿dL¿1 for men)
• For patients who have not received peripheral revascularization, an ABI of >0.90
• For patients with equivocal resting ABIs (0.91-0.99), a drop of <15% in the post-exercise ABI
• For individuals with non-compressible vessels (ABI >1.39) who have a toe- brachial index (TBI) >0.70
• Inability to speak English
• Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
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NCT02075502
Behavioral: Exercise therapy; Procedure: lower extremity ET; Procedure: peripheral open intervention
community-based participatory research; exercise adherence; endovascular therapy; claudication; community walking exercise
Peripheral Artery Disease
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Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

sfinder@umn.edu
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
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The inclusion/ exclusion criteria below, include, but are not limited to, the following: Key
Inclusion Criteria:
1. Men and women, ages 18 through 75 at the screening visit 2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD 3. A history of clinical ASCVD, for those patients who are non-HeFH. 4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening 5. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit 6. Serum LDL-C ¿ 100 mg/dL at screening (1 repeat lab is allowed) 7. Provide signed informed consent Key
Exclusion Criteria:
1. Known history of homozygous FH (clinically, or by previous genotyping) 2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins 3. Newly diagnosed diabetes (within 3 months prior to screening) 4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening) 5. Laboratory findings during screening period (not including randomization labs): 1. Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus 2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction) 3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential 4. Estimated glomerular filtration rate < 30 mL/min/1.73 m^2 5. TSH > 1.5 x ULN 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN 6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization 7. History of heart failure (New York Heart Association [NYHA] Class II-IV) within 12 months before screening 8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening 9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer) 10. Having received LDL apheresis within 2 months before screening 11. Pregnant or breast-feeding women 12. Women of childbearing potential who are unwilling to practice a highly effective birth control method 13. Sexually active men unwilling to use acceptable birth control.
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NCT03175367
Drug: Evinacumab; Drug: Matching placebo; Other: Background Lipid Modifying Therapy (LMT)
Hypercholesterolemia
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

Amanda Weller -andv0003@umn.edu
All
35 Years and over
N/A
This study is NOT accepting healthy volunteers
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General Inclusion Criteria 1. Patients ¿35 years old. 2. Carotid stenosis defined as:
• Stenosis ¿70% by catheter angiography (NASCET Criteria); OR
• by DUS with ¿70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: 1. an end diastolic velocity ¿100 cm/s, or 2. internal carotid/common carotid artery peak systolic velocity ratio ¿4.0, or 3. CTA with ¿ 70% stenosis, or 4. MRA with ¿ 70% stenosis. 3. No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18 4. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent. 5. Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization. 6. Patients must agree to comply with all protocol-specified follow-up appointments. 7. Patients must sign a consent form that has been approved by the local governing Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. 8. Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer). 9. Carotid stenosis must be treatable with CEA, CAS, or either procedure. General Exclusion Criteria 1. Intolerance or allergic reaction to a study medication without a suitable management alternative. 2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy. 3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ¿ 2) that is likely to confound study outcomes. 4. Severe dementia. 5. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation. 6. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol. 7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke. 8. Patient objects to future blood transfusions. 9. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia. 10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin inhibitor, or anti-Xa agents. 11. Chronic atrial fibrillation. 12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal atrial fibrillation that is deemed to require chronic anticoagulation. 13. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism. 14. Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization). 15. Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6 months. 16. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted value. 17. Known malignancy other than basal cell non-melanoma skin cancer. There are two exceptions to this rule: patients with prior cancer treatment and no recurrence for >5 years are eligible for enrollment and cancer patients with life expectancy of greater than 5 years are eligible for enrollment. 18. Any major surgery, major trauma, revascularization procedure, or acute coronary syndrome within the past 1 month. 19. Either the serum creatinine is ¿ 2.5 mg/dl or the estimated GFR is < 30 cc/min. 20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment. 21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung, liver, kidney). 22. Actively participating in another drug or aortic arch or cerebrovascular device trial for which participation in CREST-2 would be compromised with regard to follow-up assessment of outcomes or continuation in CREST-2. 23. Inability to understand and cooperate with study procedures or provide informed consent. 24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis following radiation therapy). 25. Previous ipsilateral CEA or CAS. 26. Ipsilateral internal or common carotid artery occlusion. 27. Intra-carotid floating thrombus. 28. Ipsilateral intracranial aneurysm > 5 mm. 29. Extreme morbid obesity that would compromise patient safety during the procedure or would compromise patient safety during the periprocedural period. 30. Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not, or cannot, be revascularized. Specific carotid endarterectomy exclusion criteria Patients who are being considered for revascularization by CEA must not have any of the following criteria: 1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication. 2. Distal/intracranial stenosis greater than index lesion. 3. Any of the following anatomical: radical neck dissection; surgically inaccessible lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits surgical exposure (e.g. spinal immobility
•inability to flex neck beyond neutral or kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal nerve palsy contralateral to target vessel; or previous extracranial-intracranial or subclavian bypass procedure ipsilateral to the target vessel. Specific Carotid Artery Stenting Exclusion Criteria Patients who are being considered for revascularization by CAS must not have any of the following criteria: 1. Allergy to intravascular contrast dye not amenable to pre-medication. 2. Type III, aortic arch anatomy. 3. Angulation or tortuosity (¿ 90 degree) of the innominate and common carotid artery that precludes safe, expeditious sheath placement or that will transmit a severe loop to the internal carotid after sheath placement. 4. Severe angulation or tortuosity of the internal carotid artery (including calyceal origin from the carotid bifurcation) that precludes safe deployment of embolic protection device or stent. Severe tortuosity is defined as 2 or more ¿ 90 degree angles within 4 cm of the target stenosis. 5. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than index lesion. Excessive circumferential calcification of the stenotic lesion defined as >3mm thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic considerations such as tortuosity, arch anatomy, and calcification must be evaluated even more carefully in elderly subjects (¿ 70 years).) 6. Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may be made from angiography of the contralateral artery. The reference diameter must be appropriate for the devices to be used. 7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD). 8. Non-contiguous lesions and long lesions (>3 cm). 9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation (common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath placement. 10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis that necessitates additional endovascular procedures to facilitate access to the aortic arch or that prevents safe and expeditious femoral access to the aortic arch. "String sign" of the ipsilateral common or internal carotid artery. 11. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries that would preclude safe passage of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
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NCT02089217
Procedure: Carotid endarterectomy (CEA); Device: Carotid Stenting (CAS); Other: Intensive Medical Management - no CEA; Other: Intensive Medical Management - no CAS
asymptomatic; carotid; stent; endarterectomy; embolic protection; medical management; hypertension; hyperlipidemia; cognition; risk factor control
Carotid Stenosis
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Patient Centered Home Exercise Program for Peripheral Artery Disease

Mary Whipple -whipp042@umn.edu
All
Not specified
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Participants with an ankle brachial index (ABI) ¿ 0.90 will be eligible for participation. 2. Participants with an ABI > 0.90 but ¿ 1.00 who experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible. 3. Participants with an ABI > 0.90 who have medical record evidence of prior lower extremity revascularization for PAD will be eligible 4. Participants with an ABI > 0.90 who have medical record evidence of PAD based on non-invasive vascular laboratory testing or based on angiographic findings will be eligible. Non-invasive vascular laboratory evidence of PAD must be obtained from a vascular laboratory.
Exclusion Criteria:
1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, non-English speaking, significant visual impairment that interferes with walking activity, hearing impairment that interferes with full study participation, unable to return to the medical center or fitness center at the expected visit frequency, or unwilling to use technology required for the intervention. 2. Individuals whose walking is limited by a condition other than PAD. 3. Greater than class II NYHA heart failure or angina. Increase in angina, angina at rest, abnormal baseline stress test. 4. Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next nine months. 5. Major medical illness including lung disease requiring oxygen, Parkinson's disease that impairs walking ability, or cancer requiring treatment in the prior two years (potential participants may still qualify if they were diagnosed with non-melanoma skin cancer in the past two years or if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent). 6. Heart attack, stroke, or coronary artery bypass surgery in the last 3 months. 7. Mini-mental status examination score < 23, dementia, or psychiatric illness. 8. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention 9. Currently enrolled in another clinical trial, exercise trial, or in cardiac rehabilitation. Currently enrolled in a clinical trial or current participation in cardiac rehabilitation or a trial of a therapeutic intervention within the past three months. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as s at least six months has passed since the participant received their final treatment in the stem cell or gene therapy study . 10. Deemed a poor candidate for the study or poorly suited for the intervention (at PI discretion).
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NCT02462824
Behavioral: Home-based exercise intervention
Peripheral Artery Disease; Peripheral Arterial Disease; PAD
Peripheral Artery Disease
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ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest

Demetris Yannopoulos, MD -yanno001@umn.edu
Emily Caldwell, BSN -caldw076@umn.edu
All
18 Years to 75 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Adult presumed or known to be 18-75 years old
• Resuscitated from OOHCA
• Initial cardiac arrest rhythm of pulseless VT/VF (including patients treated with an AED)
• No ST-segment elevation MI (No STEMI) (or STEMI-equivalent syndrome) on ED 12-lead ECG (as interpreted by a physician)
Exclusion Criteria:

• Initial non-shockable out-of-hospital cardiac arrest rhythm (pulseless electrical activity or asystole)
• Valid do not resuscitate orders (DNR),
• Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose,
• Known prisoners
• Known pregnancy,
• ST-segment elevation on ED 12-lead ECG (as interpreted by a physician)
• Absolute contraindications to emergent coronary angiography including,
• known anaphylactic reaction to angiographic contrast media,
• active gastrointestinal or internal bleeding, or
• severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure.
• Suspected or confirmed intracranial bleeding
• Refractory cardiac arrest (prior to randomization)
• Patients meeting ACCESS Trial eligibility criteria initially seen in an outside hospital and then transferred to an ACCESS Trial participating hospital
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NCT03119571
Procedure: Initial CCL admission; Diagnostic Test: Initial ICU admission
Cardiac arrest; Ventricular fibrillation; coronary artery disease
Cardiac Arrest Due to Underlying Cardiac Condition; Ventricular Fibrillation; Cardiopulmonary Arrest With Successful Resuscitation
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Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy (PREVENT II)

sfinder@umn.edu
All
50 Years and over
Phase 4
This study is NOT accepting healthy volunteers
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Inclusion Criteria
• Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
• Subject is ¿ 50 years of age
• Subject is receiving the HM II as their first LVAD
• Subject or legally authorized representative (LAR) has signed an informed consent form (ICF). Exclusion Criteria
• Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Abiomed Impella® devices
• Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
• Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (¿ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
• Subjects in whom heart transplantation is expected in ¿ 6 months
• Subjects with a known ASA allergy
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NCT02836652
Device: HeartMate II (HMII); Drug: Warfarin; Drug: acetylsalicylic acid (ASA) therapy
HeartMate II (HMII); Left Ventricular Assist Device (LVAD)
Heart Failure
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Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO)

Santiago Garcia, MD -garci205@umn.edu
All
Not specified
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Patients undergoing CTO PCI at each of the participating centers.
Exclusion Criteria:
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NCT02061436
chronic total occlusion, percutaneous coronary intervention
Coronary Artery Disease
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Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)

This study is seeking adults with a narrowed carotid artery (Carotid Stenosis). The study aims to determine the risks and benefits of surgery to remove plaque and widen the artery.
sfinder@umn.edu
Male or Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Carotid artery stenosis detectable by duplex ultrasound, with no ipsilateral carotid territory symptoms(or none for some months) and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS.
• Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG)
• Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years)
• Investigations show that both procedures (CEA and CAS) appear to be practicable and appropriate
• Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA and CAS would both be anatomically practicable.
• Doctor and patient both substantially uncertain about whether to treat with CEA or CAS, and the doctor sees no clear indication/contra-indication for either procedure
Exclusion Criteria:

• Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)
• Unsuitable for one or other procedure (eg, stenosis at carotid siphon that is inaccessible for CEA, or complex vasculature below the stenosis that would hinder CAS, or patient unfit for major surgery)
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NCT00883402
Procedure: CEA, CAS
Carotid stenosis; CEA; CAS; Stenting
Carotid Stenosis
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AdaptResponse Clinical Trial

Julie Dicken -dicke022@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Subject is willing to sign and date the study Patient Informed Consent Form.
• Subject is indicated for a CRT device according to local guidelines.
• Sinus Rhythm at time of enrollment
• Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB.
• Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment).
• Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment).
• NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Exclusion Criteria:

• Subject is less than 18 years of age (or has not reached minimum age per local law).
• Subject is not expected to remain available for at least 2 years of follow-up visits.
• Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
• Subject is, or previously has been, receiving cardiac resynchronization therapy.
• Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
• Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment.
• Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study.
• Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).
• Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study.
• Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant).
• Subject meets any exclusion criteria required by local law.
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NCT02205359
Device: aCRT ON; Device: aCRT OFF
AdaptivCRT; aCRT
Heart Failure With Left Bundle Branch Block
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High-Intensity Aerobic Lifelong Training--AF (HALT-AF)

Lin Yee Chen, MD,MBBS,MS -chenx484@umn.edu
All
18 Years to 65 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• : Patients with symptomatic non-permanent AF and aged 18-65 years who are sedentary (activity ¿0.5 hours/week of regular exercise) and seen by Dr. Chen or his cardiology colleagues at Clinics and Surgery Center (CSC), other Fairview cardiology clinics, and University of Minnesota Medical Center (UMMC). Patients will be screened and enrolled by a research coordinator.
Exclusion Criteria:

• Individuals lacking the capacity to consent for themselves will not be included, previous open heart surgery, previous catheter ablation for AF, LVEF <45%, significant cardiac valve disease, coronary heart disease without complete revascularization, implanted cardiac electronic device, or GFR <30 mL/min/1.73 m2
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NCT03241433
Other: High intensity interval training; Other: Moderate intensity continuous training; Other: No Exercise
Exercise
Atrial Fibrillation
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Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)

sfinder@umn.edu
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
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Inclusion
• Patient >18 years of age
• Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (CAD)
• Patient is eligible for PCI
• Patient is willing and able to provide informed written consent 5.3 Exclusion
• Patient not able to receive 12 months of dual anti-platelet therapy
• Failure of index PCI
• Patient or physician refusal to enroll in the study
• Patient with known CYP2C19 genotype prior to randomization
• Planned revascularization of any vessel within 30 days post-index procedure and/or of the target vessel(s) within 12 months post-procedure
• Anticipated discontinuation of clopidogrel or ticagrelor within the 12 month follow up period, example for elective surgery
• Serum creatinine >2.5 mg/dL within 7 days of index procedure
• Platelet count <80,000 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 if persistent (at least 2 abnormal values) within 7 days prior to index procedure.
• History of intracranial hemorrhage
• Known hypersensitivity to clopidogrel or ticagrelor or any of its components
• Patient is participating in an investigational drug or device clinical trial that has not reached its primary endpoint
• Patient previously enrolled in this study
• Patient is pregnant, lactating, or planning to become pregnant within 12 months
• Patient has received an organ transplant or is on a waiting list for an organ transplant
• Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the procedure
• Patient is receiving immunosuppressive therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous, etc.)
• Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)
• Concomitant use of simvastatin/lovastatin > 40 mg qd
• Concomitant use of potent CYP3A4 inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine)
• Non-cardiac condition limiting life expectancy to less than one year, per physician judgment (e.g. cancer)
• Known history of severe hepatic impairment
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
• Inability to take aspirin at a dosage of 100 mg or less
• Current substance abuse (e.g., alcohol, cocaine, heroin, etc.)
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NCT01742117
Drug: Clopidogrel; Drug: Ticagrelor; Genetic: Retrospective Genotype testing; Genetic: Prospective Genotype testing
percutaneous coronary intervention; angioplasty
Coronary Artery Disease; Acute Coronary Syndrome; Stenosis
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Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) (COAPT)

Emily Caldwell -caldw076@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Symptomatic functional MR (¿3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology. Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present. Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ¿92%) 2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated. 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. 4. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group. 5. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ¿300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ¿1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ¿92%). 6. Left Ventricular Ejection Fraction (LVEF) is ¿20% and ¿50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). 7. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant. 8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN). 9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator. 10. Age 18 years or older. 11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial. 12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent. 13. Left Ventricular End Systolic Dimension (LVESD) is ¿ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration. For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study. COAPT CAS study
Inclusion Criteria:
1. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).
Exclusion Criteria:
1. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use. 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration. 4. Percutaneous coronary intervention within 30 days prior to subject registration. 5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration. 6. Tricuspid valve disease requiring surgery or transcatheter intervention. 7. Aortic valve disease requiring surgery. 8. Cerebrovascular accident within 30 days prior to subject registration. 9. Severe symptomatic carotid stenosis (> 70% by ultrasound). 10. Carotid surgery or stenting within 30 days prior to subject registration. 11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure. 12. Presence of any of the following:
• Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
• Hemodynamic instability requiring inotropic support or mechanical heart assistance. 13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site. 14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration. 15. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration. 16. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:
• Insufficient mobile leaflet available for grasping with the MitraClip device
• Evidence of calcification in the grasping area
• Presence of a significant cleft in the grasping area
• Lack of both primary and secondary chordal support in the grasping area
• Leaflet mobility length < 1 cm 17. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. 19. Life expectancy < 12 months due to non-cardiac conditions. 20. Modified Rankin Scale ¿ 4 disability. 21. Status 1 heart transplant or prior orthotopic heart transplantation. 22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure. 23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated). 25. Active infections requiring current antibiotic therapy. 26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk. 27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically. 28. Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. 29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 30. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study. COAPT CAS study
Exclusion Criteria:
1. Subjects must not meet any of the above COAPT RCT exclusion criteria.
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NCT01626079
Device: MitraClip System
Functional Mitral Regurgitation; Mitral Valve Regurgitation; Symptomatic Heart Failure; Functional MR; MitraClip; Mitral Valve Insufficiency; Cardiopulmonary exercise testing; COAPT CAS; COAPT Continued Access Study; MitraClip NT
Mitral Regurgitation; Mitral Valve Regurgitation; Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects; Heart Failure
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Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease

Otto A Sanchez, M.D., Ph.D. -sanc0050@umn.edu
All
18 Years to 80 Years old
Phase 2
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Subject with symptoms of intermittent claudication, such as exercise-induced pain, cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the leg(s) (calf, thigh, buttocks), relieved by rest. 2. Ankle-brachial index ¿ 0.90 acquired according to the American Heart Association guidelines. 3. Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting pressure (or loss of previously present Doppler signal for both the posterior tibial and anterior tibial arteries immediately after exercise if arteries were incompressible). 4. Patients on medical treatment for PAD without significant improvement in intermittent claudication within the last 6 months.
Exclusion Criteria:
1. Age < 18 and > 80 years. 2. Patients with physician diagnosed chronic kidney disease or heart failure stage II or IV or unstable angina. 3. Echocardiographic evidence of cardiomyopathies and pulmonary hypertension. 4. Patients that have received cancer treatment within the last year (except skin cancer). 5. Severe limitations in mobility due to osteomuscular disorders present at time of interview. 6. Dementia or other mental disorders that prevent patients from following a research protocol present at time of interview 7. Patients engaged in an exercise rehabilitation program within the past 6 months. 8. Patients schedule to undergo an arterial revascularization procedure during the study or have undergone one within the past 6 months. 9. Inconsistent maximal walking distance on the treadmill test.
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NCT02636283
Drug: Entresto; Drug: Placebo group
Peripheral Arterial Disease
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Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension (PGEN for HTN)

pgenstudy@fairview.org
All
30 Years to 70 Years old
Phase 2
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Subject with new diagnosis of hypertension or uncontrolled hypertension 2. Subject is able and willing to provide informed consent 3. Subject is ¿ 30 and ¿ 70 years of age 4. Subject with a Body Mass Index (BMI) ¿ 19 and ¿ 35
Exclusion Criteria:
1. Subject has diagnosed chronic kidney disease as determined by: a. Serum creatinine 1.3mg/dl 2. Subject has clinically significant cardiac disease as determined by: 1. Diagnosed coronary artery disease 2. Diagnosed heart failure 3. Congenital cardiac disease 3. Subject has clinically significant vascular disease as determined by: 1. Diagnosed peripheral vascular disease 2. Diagnosed pulmonary hypertension 4. Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy. 5. Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months 6. Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months. 7. Subject has liver disease or impaired liver function?
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NCT02988245
Drug: Prescription Drugs
Hypertension
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CardiAMP¿ Heart Failure Trial

Coley Landvik, RN -clandvik@umn.edu
All
21 Years to 90 Years old
Phase 3
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• New York Heart Association (NYHA) Class II or III
• A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
• On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
• Left ventricular ejection fraction between 20% and 40%.
Exclusion Criteria:
¿ Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
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NCT02438306
Biological: Autologous cell therapy; Other: Sham
Heart Failure
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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED)

Orly Vardeny, PharmD, MS -ovardeny@umn.edu
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• >= 18 years of age
• history of hospitalization for myocardial infarction within 1 year of enrollment OR a history of hospitalization for heart failure within 2 years of enrollment
• At least one of the following additional risk factors:
• Prior MI (if HF the index event above; or a second MI)
• Prior HF hospitalization (if MI the index event above; or a second HF event)
• Age ¿ 65
• LVEF < 40%
• Diabetes mellitus
• Obesity (BMI ¿ 30)
• Renal impairment (eGFR ¿ 60)
• History of ischemic stroke
• History of peripheral artery disease
• Current smoking
Exclusion Criteria:

• Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6 weeks after influenza vaccine
• Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months.
• Receipt of influenza vaccine during current influenza season
• Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.
• Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.
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NCT02787044
Biological: High Dose Trivalent Influenza Vaccine; Biological: Standard Dose Quadrivalent Influenza Vaccine
influenza vaccine; cardiopulmonary hospitalization; heart failure; myocardial infarction; clinical trial
Heart Failure; Myocardial Infarction
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