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Functional MRI of the Lower Extremities

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised exercise therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Healthy Controls

Age-Matched Controls

PAD Patients

Arm Description

Subjects without PAD who have the same average age as the PAD patients

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

Outcomes

Primary Outcome Measures

Stress-rest calf-muscle perfusion
Perfusion in the different calf muscle groups following exercises of low (rest) and high (stress) intensities
Perfusion changes following supervised exercise therapy
Change in stress-rest calf-muscle perfusion in PAD patients following the 12-week supervised exercise therapy

Secondary Outcome Measures

Full Information

First Posted
January 23, 2018
Last Updated
September 11, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03423316
Brief Title
Functional MRI of the Lower Extremities
Official Title
Stress-rest Calf Muscle Perfusion: a Functional Diagnostic Test for Peripheral Arterial Disease (PAD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Title
Age-Matched Controls
Arm Type
No Intervention
Arm Description
Subjects without PAD who have the same average age as the PAD patients
Arm Title
PAD Patients
Arm Type
Experimental
Arm Description
Patients with PAD. Approximately 75% of PAD patients will be enrolled in the 12-week exercise therapy program.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress-rest calf-muscle perfusion
Description
Perfusion in the different calf muscle groups following exercises of low (rest) and high (stress) intensities
Time Frame
Single visit (~90 minutes)
Title
Perfusion changes following supervised exercise therapy
Description
Change in stress-rest calf-muscle perfusion in PAD patients following the 12-week supervised exercise therapy
Time Frame
Before and after supervised exercise therapy (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang
Phone
6177268627
Email
jeff.zhang@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Conlin

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional MRI of the Lower Extremities

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