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

Vanderbilt University Medical Center

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: Vascular Assessment; Behavioral: Supervised Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03490968

180441

18SFRN33900069 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Healthy Subjects

Other group

Treatment:

Behavioral: Vascular Assessment

Peripheral Artery Disease (PAD) with Supervised Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Vascular Assessment

Behavioral: Supervised Exercise

PAD Subjects Who Undergo Revascularization of the Leg

Active Comparator group

Description:

This group of subjects are receiving leg revascularization as part of standard of care.

Treatment:

Behavioral: Vascular Assessment