Stress-rest Calf Muscle Perfusion: a Functional Diagnostic Test for Peripheral Arterial Disease (PAD)
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Stress-rest calf-muscle perfusion
研究概览
简要总结
In this project, the investigators propose to use high-resolution magnetic resonance imaging (MRI) to measure blood perfusion in different groups of calf muscle. This imaging approach is standard of care for evaluation of coronary artery disease (CAD), and has never been successfully applied to PAD. Preliminary results show distinct patterns of muscle perfusion between healthy and PAD patients, and thus great promise of the technique. The investigators will first verify the reproducibility of the technique, and then compare the calf muscle perfusion measures in PAD patients against healthy age-matched controls. This comparison will test the feasibility of detecting functional abnormality in PAD patients. After the baseline scans, the PAD patients will opt to undergo a 12-week supervised exercise therapy, and then a post-therapy MRI scan. Comparison of the pre- and post-therapy measurements will indicate how the therapy improves the calf-muscle perfusion, and how this perfusion change correlates with increases in patient's walking ability.
The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention. The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PAD patients with
- •Intermittent claudication
- •Ankle-brachial blood-pressure index (ABI) < 0.9
排除标准
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Chronic pulmonary diseases
- •Arthritis or other joint ailments
结局指标
主要结局
Stress-rest calf-muscle perfusion
时间窗: Single visit (~90 minutes)
Perfusion in the different calf muscle groups following exercises of low (rest) and high (stress) intensities
Perfusion changes following supervised exercise therapy
时间窗: Before and after supervised exercise therapy (12 weeks)
Change in stress-rest calf-muscle perfusion in PAD patients following the 12-week supervised exercise therapy
次要结局
未报告次要终点
研究者
Jeff L. Zhang, PhD
Assistant Professor
Massachusetts General Hospital
