The Impact of Branched-Chain Amino Acid Metabolism on Limb Dysfunction in PAD (MicroPAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- C3/C5acylcarnitine levels in healthy control subjects.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
- •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.
研究组 & 干预措施
Healthy Subjects
干预措施: Vascular Assessment (Behavioral)
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.
干预措施: Supervised Exercise (Behavioral)
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.
干预措施: Vascular Assessment (Behavioral)
PAD Subjects Who Undergo Revascularization of the Leg
This group of subjects are receiving leg revascularization as part of standard of care.
干预措施: Vascular Assessment (Behavioral)
结局指标
主要结局
C3/C5acylcarnitine levels in healthy control subjects.
时间窗: baseline
C3/C5 acylcarnitine levels in PAD surgical bypass group
时间窗: Change from baseline to 12 weeks
C3/C5acylcarnitine levels in PAD exercise group after 12 weeks
时间窗: Change from baseline to 12 weeks
次要结局
未报告次要终点
研究者
Joshua Beckman
Professor
Vanderbilt University Medical Center