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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490968
• Other study ID #: 180441
• Secondary ID: 18SFRN33900069
• Status: Completed
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: August 22, 2023

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Supervised Exercise
Subjects will have 3 visits per week for 12 weeks.
• Vascular Assessment
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C3/C5acylcarnitine levels in healthy control subjects.		baseline
Primary	C3/C5acylcarnitine levels in PAD exercise group after 12 weeks		Change from baseline to 12 weeks
Primary	C3/C5 acylcarnitine levels in PAD surgical bypass group		Change from baseline to 12 weeks