Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Not Applicable

Terminated

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Exercise

• Registration Number: NCT02388685
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-17
• Primary Completion: 2020-06
• Status Verified: 2023-11
• Study Completion: 2023-11-22
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home exercise	Exercise	Patients will undergo home exercise therapy under the supervision of the exercise laboratory

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States