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The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490968
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Joshua Beckman, Vanderbilt University Medical Center

Study Description
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Brief Summary:
Test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Behavioral: Supervised Exercise Behavioral: Vascular Assessment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Healthy Subjects Behavioral: Vascular Assessment

Screen: Subjects will undergo a H&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.

Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.

Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.
Experimental: Peripheral Artery Disease (PAD) with Supervised Exercise
Subjects will be referred for supervised exercise therapy. Subjects will have 3 visits per week for 12 weeks. Each visit will include a minimum of 30 to 40 minutes of exercise to improve ambulation with a certified trainer.
 Behavioral: Supervised Exercise
Subjects will have 3 visits per week for 12 weeks.

Behavioral: Vascular Assessment

Screen: Subjects will undergo a H&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.

Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.

Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.
Active Comparator: PAD Subjects Who Undergo Revascularization of the Leg
This group of subjects are receiving leg revascularization as part of standard of care.
 Behavioral: Vascular Assessment

Screen: Subjects will undergo a H&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.

Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.

Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated.


Outcome Measures
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Primary Outcome Measures :
  1. C3/C5acylcarnitine levels in healthy control subjects. [ Time Frame: baseline ]
  2. C3/C5acylcarnitine levels in PAD exercise group after 12 weeks [ Time Frame: Change from baseline to 12 weeks ]
  3. C3/C5 acylcarnitine levels in PAD surgical bypass group [ Time Frame: Change from baseline to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion/exclusion criteria for Healthy Subjects

Inclusion criteria

  • Male or female, age ≥ 50 years old
  • Non-smoker

Exclusion criteria

  • Presence of peripheral artery disease
  • History of a heart attack or stroke
  • Diabetes
  • Active cancer
  • Severe renal disease (CrCl < 60)
  • Severe liver disease
  • Active rheumatological diseases

Inclusion/exclusion criteria for PAD Subjects

Inclusion criteria

  • Male or female, age 50 years or older
  • Atherosclerotic PAD, ABI ≤0.85
  • Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent
  • For Aim 3, subjects will have Rutherford stage 4 or 5 disease
  • For Aim 3, subjects will be undergoing revascularization as standard of care

Exclusion criteria

  • Presence of a femoral, popliteal or tibial aneurysm of the index limb
  • Life expectancy less than 2 years
  • A vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure
  • Renal dysfunction defined as MDRD eGFR ≤ 20ml/min/173 m2 at the time of screening
  • Currently on dialysis or history of a renal transplant
  • Cirrhosis or active hepatitis
  • A documented hypercoagulable state
  • Myocardial infarction within 6 months
  • Stroke within 6 months
  • Nonatherosclerotic occlusive disease of the lower extremity
  • Any prior infrainguinal revascularization on index limb
  • Current immunosuppressive medication, chemotherapy or radiation therapy
  • Inability to have an MRI
  • Exercise limitation aside from that due to PAD (i.e. COPD, degenerative joint disease, etc.)
  • Women who are pregnant
  • Women who are nursing
  • Primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490968


Contacts
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Contact: Emily Shardelow, BS +1 (615) 875-8949 emily.m.shardelow@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Shardelow, BS         
Principal Investigator: Joshua Beckman, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
American Heart Association
Investigators
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Principal Investigator: Joshua Beckman, MD Vanderbilt University Medical Center
More Information
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Responsible Party: Joshua Beckman, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03490968    
Other Study ID Numbers: 180441
18SFRN33900069 ( Other Grant/Funding Number: American Heart Association )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases