Clinical trial NCT02388685: Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
Official title: Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
exercise
perfusion
energetics
magnetic resonance imaging
magnetic resonance spectroscopy
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 16
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Exercise calf muscle perfusion
timeFrame: Change from baseline at 12 weeks
measure: Exercise calf muscle energetics
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Calf muscle capillary density
timeFrame: Change from baseline at 12 weeks
measure: Treadmill testing
timeFrame: Change from baseline at 12 weeks
measure: 6-minute walk test
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Christopher M Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References: