The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- C3/C5acylcarnitine levels in healthy control subjects.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
- •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.
Arms & Interventions
Healthy Subjects
Intervention: Vascular Assessment (Behavioral)
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.
Intervention: Supervised Exercise (Behavioral)
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.
Intervention: Vascular Assessment (Behavioral)
PAD Subjects Who Undergo Revascularization of the Leg
This group of subjects are receiving leg revascularization as part of standard of care.
Intervention: Vascular Assessment (Behavioral)
Outcomes
Primary Outcomes
C3/C5acylcarnitine levels in healthy control subjects.
Time Frame: baseline
C3/C5 acylcarnitine levels in PAD surgical bypass group
Time Frame: Change from baseline to 12 weeks
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
Time Frame: Change from baseline to 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Joshua Beckman
Professor
Vanderbilt University Medical Center