Functional MRI of the Lower Extremities

Not Applicable

• Conditions: Peripheral Arterial Disease
• Interventions: Behavioral: Supervised exercise therapy

• Registration Number: NCT03423316
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In this project, the investigators propose to use high-resolution magnetic resonance imaging (MRI) to measure blood perfusion in different groups of calf muscle. This imaging approach is standard of care for evaluation of coronary artery disease (CAD), and has never been successfully applied to PAD. Preliminary results show distinct patterns of muscle perfusion between healthy and PAD patients, and thus great promise of the technique. The investigators will first verify the reproducibility of the technique, and then compare the calf muscle perfusion measures in PAD patients against healthy age-matched controls. This comparison will test the feasibility of detecting functional abnormality in PAD patients. After the baseline scans, the PAD patients will opt to undergo a 12-week supervised exercise therapy, and then a post-therapy MRI scan. Comparison of the pre- and post-therapy measurements will indicate how the therapy improves the calf-muscle perfusion, and how this perfusion change correlates with increases in patient's walking ability.

The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention. The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16
• Study Start: 2020-10-31
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

PAD patients with

• Intermittent claudication
• Ankle-brachial blood-pressure index (ABI) < 0.9

Exclusion Criteria

• Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
• Chronic pulmonary diseases
• Arthritis or other joint ailments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAD Patients	Supervised exercise therapy	Patients with PAD. Approximately 75% of PAD patients will be enrolled in the 12-week exercise therapy program.

Primary Outcome Measures

Name	Time	Method
Stress-rest calf-muscle perfusion	Single visit (~90 minutes)	Perfusion in the different calf muscle groups following exercises of low (rest) and high (stress) intensities
Perfusion changes following supervised exercise therapy	Before and after supervised exercise therapy (12 weeks)	Change in stress-rest calf-muscle perfusion in PAD patients following the 12-week supervised exercise therapy

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States