Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Sponsor

University of Virginia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02388685

Collaborator

(none)

Enrollment

Location

Arms

107

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Other: Exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Home exercise Patients will undergo home exercise therapy under the supervision of the exercise laboratory	Other: Exercise Home exercise therapy
No Intervention: No exercise Patients will continue with usual care

Arm

Intervention/Treatment

Experimental: Home exercise

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

Other: Exercise

Home exercise therapy

No Intervention: No exercise

Patients will continue with usual care

Outcome Measures

Primary Outcome Measures

Exercise calf muscle perfusion [Change from baseline at 12 weeks]
Arterial spin labeling MRI at peak exercise
Exercise calf muscle energetics [Change from baseline at 12 weeks]
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise

Secondary Outcome Measures

Calf muscle capillary density [Change from baseline at 12 weeks]
Biopsy sample of calf muscle for capillary density
Treadmill testing [Change from baseline at 12 weeks]
Treadmill testing with peak VO2 measures
6-minute walk test [Change from baseline at 12 weeks]
6-minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)