Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Exercise calf muscle perfusion
研究概览
简要总结
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).
详细描述
The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented ABI 0.5-0.9
- •Ability to walk on treadmill
排除标准
- •Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- •Critical limb ischemia
- •Known or suspected peripheral neuropathy, heel cord contracture and foot deformity
- •Other conditions that limit walking, e.g. lung disease or arthritis
- •Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent (<2 months) myocardial infarction,
- •BMI > 40,
- •Known contraindication to MRI (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.)
- •Allergy to lidocaine or xylocaine (local anesthetic)
结局指标
主要结局
Exercise calf muscle perfusion
时间窗: Change from baseline at 12 weeks
Arterial spin labeling MRI at peak exercise
Exercise calf muscle energetics
时间窗: Change from baseline at 12 weeks
Phosphocreatine recovery kinetics by MR spectroscopy at end exercise
次要结局
- Calf muscle capillary density(Change from baseline at 12 weeks)
- Treadmill testing(Change from baseline at 12 weeks)
- 6-minute walk test(Change from baseline at 12 weeks)
研究者
Christopher Kramer
Professor of Radiology
University of Virginia