Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Peripheral Arterial Disease Clinical Trial

Official title:

Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02388685
• Other study ID #: IRB-HSR# 16084
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: November 22, 2023

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 22, 2023
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Exercise
Home exercise therapy

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise calf muscle perfusion	Arterial spin labeling MRI at peak exercise	Change from baseline at 12 weeks
Primary	Exercise calf muscle energetics	Phosphocreatine recovery kinetics by MR spectroscopy at end exercise	Change from baseline at 12 weeks
Secondary	Calf muscle capillary density	Biopsy sample of calf muscle for capillary density	Change from baseline at 12 weeks
Secondary	Treadmill testing	Treadmill testing with peak VO2 measures	Change from baseline at 12 weeks
Secondary	6-minute walk test	6-minute walk test	Change from baseline at 12 weeks