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临床试验/NCT03423316
NCT03423316Unknown不适用

Stress-rest Calf Muscle Perfusion: a Functional Diagnostic Test for Peripheral Arterial Disease (PAD)

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
1
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

研究组 & 干预措施

Healthy Controls

No Intervention

Age-Matched Controls

No Intervention

Subjects without PAD who have the same average age as the PAD patients

PAD Patients

Experimental

Patients with PAD. Approximately 75% of PAD patients will be enrolled in the 12-week exercise therapy program.

干预措施: Supervised exercise therapy (Behavioral)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff L. Zhang, PhD

Assistant Professor

Massachusetts General Hospital

研究点 (1)

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