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

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

- Absolute contraindication to iodinated contrast

- 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