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

  • STATUS
    Recruiting
  • End date
    Mar 18, 2023
  • participants needed
    100
  • sponsor
    Vanderbilt University Medical Center
Updated on 4 March 2022
revascularisation
Accepts healthy volunteers

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.

Details
Condition Peripheral Arterial Disease
Treatment Supervised exercise, Vascular Assessment
Clinical Study IdentifierNCT03490968
SponsorVanderbilt University Medical Center
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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