Peripheral Arterial Disease
Conditions
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.
Interventions
BEHAVIORALSupervised Exercise
Subjects will have 3 visits per week for 12 weeks.
BEHAVIORALVascular 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.
Sponsors
American Heart Association
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion/
Exclusion criteria
for Healthy Subjects Inclusion criteria * Male or female, age ≥ 50 years old * Non-smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C3/C5acylcarnitine levels in healthy control subjects. | baseline |
| C3/C5acylcarnitine levels in PAD exercise group after 12 weeks | Change from baseline to 12 weeks |
| C3/C5 acylcarnitine levels in PAD surgical bypass group | Change from baseline to 12 weeks |
Countries
United States
Outcome results
None listed