Purpose

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.

Condition

Eligibility

Eligible Ages
Over 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Healthy Subjects
  • Behavioral: 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.
Experimental
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.
  • Behavioral: Supervised Exercise
    Subjects will have 3 visits per week for 12 weeks.
  • Behavioral: 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.
Active Comparator
PAD Subjects Who Undergo Revascularization of the Leg
This group of subjects are receiving leg revascularization as part of standard of care.
  • Behavioral: 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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Emily Shardelow, BS

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Emily Shardelow, BS
+1 (615) 875-8949
emily.m.shardelow@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.