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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 : December 19, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Joshua Beckman, Vanderbilt University Medical Center

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

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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 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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 bypass surgery patients will return in 12 weeks and have the testing visit 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 bypass surgery patients will return in 12 weeks and have the testing visit repeated.


Active Comparator: PAD with Leg Bypass Surgery
This group of patients are receiving leg bypass surgery 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 bypass surgery patients will return in 12 weeks and have the testing visit repeated.





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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Healthy volunteers

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

PAD patients

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

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

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 Banks, BS +1 (615) 875-8949 emily.s.banks@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Banks, 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

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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: December 19, 2019
Last Verified: June 2019
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