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Study matches: 16

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.
sfinder@umn.edu
Male or Female
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; Malignant Childhood 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)

Adam Greer -gree1543@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
Phase 1
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. History of treatment for hypertension 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
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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HALO: A Single Arm Prospective Investigation of the SJM¿ Masters HP¿ 15mm Rotatable Mechanical Heart Valve

sfinder@umn.edu
All
up to 5 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
1. Subject requires mitral valve replacement.* *Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria. 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.
Exclusion Criteria:
1. Subject is > 5 years of age. 2. Subject has a contraindication to anticoagulant/antiplatelet medication. 3. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.* *Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study. 4. Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve. 5. Subject has active endocarditis. 6. Subject has active myocarditis. 7. Subject has an acute preoperative neurological deficit that has not returned to baseline or stabilized ¿ 30 days prior to the study procedure. 8. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ¿ 48 hours prior to the study procedure. 9. Subject has a non-cardiac illness resulting in a life expectancy of < 1 year. 10. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure. 11. Subject has been previously enrolled and implanted in this study. 12. Subject is participating in another study for an investigational drug and/or device. 13. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results.
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NCT02097420
Device: Mitral valve replacement SJM¿ Masters HP¿ 15mm Rotatable Mechanical Heart Valve
Mitral valve
Mitral Valve Disease; Damaged Mitral Valve; Malfunctioning Mitral Heart Valve; Mitral Valve Replacement
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Treatment of Masked Hypertension

This study is seeking persons from 18 to 75 years old who have masked hypertension (high blood pressure most of the time but normal blood pressure during doctor's office visits). This study aims to determine the effectiveness of blood pressure medications for treating masked hypertension.
Paul E Drawz, MD, MHS, MS -draw0003@umn.edu
Male or Female
18 Years to 75 Years old
Phase 4
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• Age 18-75 years
• 30 < eGFR < 70 ml/min/1.73m2 within 9 months of the screening visit
• Urine albumin to creatinine ratio >100mg/gm OR a urinalysis with ¿30mg/dL albuminuria within 9 months of the screening visit
• Most recent clinic systolic BP >120 and <140 mmHg within 9 months of the screening visit
• Masked hypertension at the screening and baseline visits
• Clinic systolic BP <140 mmHg
• 24hr ambulatory systolic BP > 130 mmHg
• Taking ¿ 2 antihypertensive medications
• No change in antihypertensive medications for the past 6 months
Exclusion Criteria:

• Heart failure
• Lightheaded with standing
• Loss of consciousness in the past 24 months
• Non-English speakers
• History of breast cancer requiring a mastectomy or radiation on the side of the non-dominant arm and unable or refuses to use the dominant arm for ambulatory BP monitoring
• Cardiovascular event or procedure or hospitalization for unstable angina within the last 3 months
• Inability to perform ambulatory BP monitoring due to compliance or other clinical reason
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NCT02142881
Other: Antihypertensive medication intensification; Other: Usual care
Masked Hypertension; Hypertension; Chronic Renal Insufficiency
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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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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:
Show full eligibility criteria
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
Hide eligibility criteria
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
Male or Female
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
Hide eligibility criteria
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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Management of Bleeding Following Cardiopulmonary Bypass

This study is open to both men and women up to age 75 who are planning to have open-heart surgery. The study will monitor blood loss during surgery and the effectiveness of a therapy designed to minimize blood loss.
Marie E Steiner, MD, MS -stein083@umn.edu
Male or Female
up to 75 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients: 1. undergoing repeat sternotomy, or 2. undergoing combined procedures (i.e.
•valve and coronary artery surgery), or 3. undergoing multiple valve surgery, or 4. undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or 5. undergoing complex congenital cardiac surgery
Exclusion Criteria:
Ineligible patients include those: 1. with known coagulation factor deficiency, or 2. refusing to receive donor blood products if necessary, or 3. undergoing emergency surgery, or 4. undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or 5. with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction [if not replacing this valve in upcoming operation], renal vein thrombosis, acute MI, DVT ), or 6. with known thrombophilia, or 7. with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia) 8. pregnant, or 9. weight > 150 kg or < 18 kg
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NCT00672516
hemorrhage; cardiopulmonary bypass; blood component transfusion; hemostasis, surgical
Hemorrhage; Cardiopulmonary Bypass
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Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI)

Emily Caldwell -caldw076@umn.edu
Barbara Bruhn-Ding -bruhn028@umn.edu
Male or Female
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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Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II) (SHIELD II)

sfinder@umn.edu
All
18 Years to 100 Years old
N/A
This study is NOT accepting healthy volunteers
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Inclusion Criteria:

• At least 18 years of age
• Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
• Patient is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
• A heart team, including a cardiac surgeon, has determined high risk PCI is an acceptable therapeutic option
• The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as: o an ejection fraction of ¿35% AND at least one of the following:
• intervention of the last patent coronary conduit, OR
• intervention of an unprotected left main artery, OR
• intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories
• Written, signed, and dated informed consent
Exclusion Criteria:

• ¿ Emergency PCI
• Any prior coronary revascularization within the last six months
• Myocardial infarction at baseline defined as: ST Elevation MI (STEMI): Subject has clinical symptoms and/or ECG changes (new pathological Q waves in 2 contiguous leads) consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure. Non-STEMI: Hemodynamically unstable with biomarker elevation (CK-MB or Troponin >1x URL) and/or no evidence of at least 1 consecutive troponin or CK-MB value trending downward from previous value. URL = upper range limit, defined as 99th percentile of normal reference range
• Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
• Hemodynamic support with the HeartMate PHP post-PCI is anticipated
• Cardiogenic shock (systolic blood pressure (SBP) <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium AND cardiac index <2.2 L/min/m2)
• Mural thrombus in the left ventricle
• History of aortic valve replacement
• Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
• Moderate to severe aortic insufficiency by echocardiographic assessment
• Severe peripheral vascular disease
• Known abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
• Patient is on hemodialysis
• Liver dysfunction with elevation of liver enzymes and bilirubin levels to ¿ 3x upper limit of normal (ULN) or INR (International Normalized Ratio) ¿2 or lactate dehydrogenase (LDH) > 2.5x ULN.
• Uncorrectable abnormal coagulation parameters (platelet count ¿75000/mm3 or INR ¿2.0 or fibrinogen ¿1.5 g/l)
• Active systemic infection requiring treatment with antibiotics
• Stroke or transient ischemic attack (TIA) within 6 month of procedure
• Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
• Patient is pregnant
• Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
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NCT02468778
Device: HeartMate PHP; Device: Any Abiomed Impella® device approved for use in high-risk PCI
HeartMate PHP; High Risk PCI; Left Ventricular Dysfunction; Thoratec Corporation
Coronary Artery 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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