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Completed

NCT Number: NCT03490968

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised exercise

Behavioral

Subjects will have 3 visits per week for 12 weeks.

Vascular Assessment

Behavioral

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2018
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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