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Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

NCT ID: NCT02388685

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2023-11-22

Brief Summary

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The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).

Detailed Description

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The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.

Conditions

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Peripheral Arterial Disease

Keywords

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peripheral arterial disease exercise perfusion energetics magnetic resonance imaging magnetic resonance spectroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home exercise

Patients will undergo home exercise therapy under the supervision of the exercise laboratory

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Home exercise therapy

No exercise

Patients will continue with usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Home exercise therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented ABI 0.5-0.9
* Ability to walk on treadmill

Exclusion Criteria

* Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
* Critical limb ischemia
* Known or suspected peripheral neuropathy, heel cord contracture and foot deformity
* Other conditions that limit walking, e.g. lung disease or arthritis
* Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent (\<2 months) myocardial infarction,
* BMI \> 40,
* Known contraindication to MRI (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.)
* Allergy to lidocaine or xylocaine (local anesthetic)
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Christopher Kramer

Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher M Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-HSR# 16084

Identifier Type: -

Identifier Source: org_study_id