Functional MRI of the Lower Extremities

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03423316
• Other study ID #: 2019P001781
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: July 2021

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: Lei Zhang
• Phone: 6177268627
• Email: jeff.zhang[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Supervised exercise therapy
The therapy will be conducted three times each week for 12 weeks. Each session takes 1 hour, consisting of 5 minutes of warmup activities, 50 minutes of intermittent exercise, and 5 minutes of cool-down activities. Exercise consists of walking on a treadmill initiated at 2 mph and 0% grade, until claudication pain becomes moderately severe. After claudication pain subsides, the subject will restart the walk. At the end of the session, the total exercise duration will be recorded. After a patient is able to walk 8-10 minutes at the initial workload, the grade is increased by 1-2%, or the speed is increased by 0.5 mph as tolerated.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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