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Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Primary Purpose

Peripheral Arterial Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home exercise

No exercise

Arm Description

Patients will undergo home exercise therapy under the supervision of the exercise laboratory

Patients will continue with usual care

Outcomes

Primary Outcome Measures

Exercise calf muscle perfusion
Arterial spin labeling MRI at peak exercise
Exercise calf muscle energetics
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise

Secondary Outcome Measures

Calf muscle capillary density
Biopsy sample of calf muscle for capillary density
Treadmill testing
Treadmill testing with peak VO2 measures
6-minute walk test
6-minute walk test

Full Information

First Posted
March 4, 2015
Last Updated
November 9, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02388685
Brief Title
Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
Official Title
Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home exercise
Arm Type
Experimental
Arm Description
Patients will undergo home exercise therapy under the supervision of the exercise laboratory
Arm Title
No exercise
Arm Type
No Intervention
Arm Description
Patients will continue with usual care
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Home exercise therapy
Primary Outcome Measure Information:
Title
Exercise calf muscle perfusion
Description
Arterial spin labeling MRI at peak exercise
Time Frame
Change from baseline at 12 weeks
Title
Exercise calf muscle energetics
Description
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Calf muscle capillary density
Description
Biopsy sample of calf muscle for capillary density
Time Frame
Change from baseline at 12 weeks
Title
Treadmill testing
Description
Treadmill testing with peak VO2 measures
Time Frame
Change from baseline at 12 weeks
Title
6-minute walk test
Description
6-minute walk test
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Kramer, MD
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

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