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Clinical Trials/NCT03423316
NCT03423316
Unknown
Not Applicable

Stress-rest Calf Muscle Perfusion: a Functional Diagnostic Test for Peripheral Arterial Disease (PAD)

Massachusetts General Hospital1 site in 1 country90 target enrollmentOctober 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Massachusetts General Hospital
Enrollment
90
Locations
1
Primary Endpoint
Stress-rest calf-muscle perfusion
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2020
End Date
July 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeff L. Zhang, PhD

Assistant Professor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stress-rest calf-muscle perfusion

Time Frame: 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

Time Frame: 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

Study Sites (1)

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