Effect of Remote Ischemic Conditioning on Vascular Health in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Flow mediated dilation
研究概览
简要总结
The main aim of the current study is to assess cardiovascular effects of remote ischemic conditioning in patients who have suffered from stroke. A group of stroke patients will be subjected to four weeks of daily remote ischemic conditioning and four weeks of placebo and vascular function is assessed as a primary outcome.
详细描述
Remote ischemic preconditioning (RIC) has been shown to reduce myocardial damage in association with a myocardial infarct but less is known about the potential effects on vascular function in patients who have suffered a stroke. RIC is a procedure by which blood flow to a limb is repeatedly occluded during a short period by an inflatable cuff. This project evaluates the effect of a two week period with RIC on vascular function and cerebral blood flow velocity as well as on factors associated with blood clot formation in patients who have suffered a stroke. The study also aims to provide mechanistic insight into the beneficial effects of the RIC procedure.
Subjects are patients who within the past five years have suffered from lacunar infarct. The study is of a cross-over design with two weeks of homebased RIC treatment and two weeks of control period in a randomized order. Before and after the experimental periods the subjects undergo a number of tests assessing general health status, vascular function and cerebral blood flow velocity. Skeletal muscle samples are obtained for the determination of selected proteins related to vascular function and angiogenesis and blood samples are obtained for the determination of platelet function.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Clinical symptoms and corresponding computer tomographytomography/magnetic resonance (CT/MR)-scanning results for lacunar infarct within past five years.
- •Small vessel disease stroke (lacunar infarct) is defined by the TOAST criteria
排除标准
- •Clinical significant carotid stenosis. Cardioembolic stroke
- •Clinically significant chronic diseases other than lacunar infarct and associated factors
- •Current or past smoker within the past ten years
- •Current treatment with beta-blockers, peroral steroids or NSAIDS
- •Alcohol- or drug-addiction.
- •Pregnant or lactating.
- •Inability to understand the content of the study information provided.
结局指标
主要结局
Flow mediated dilation
时间窗: Change from baseline to 4 weeks
Assessment of brachial artery dilation after 5 min occlusion of upper arm by cuff
次要结局
- Plasma lipids(Change from baseline to 4 weeks)
- Skeletal muscle blood flow(Change from baseline to 4 weeks)
- Blood clot structure-gel point(Change from baseline to 4 weeks)
- Blood clot structure-fractal analysis(Change from baseline to 4 weeks)
- Platelet reactivity(Change from baseline to 4 weeks)
- Skeletal muscle proteins(Change from baseline to 4 weeks)
- Plasma proteins(Change from baseline to 4 weeks)
- Cerebral vascular function-visual task(Change from baseline to 4 weeks)
- Cerebral vascular function- motorparadigm task(Change from baseline to 4 weeks)
- Oral glucose tolerance test (OGTT)(Change from baseline to 4 weeks)
- Body composition(Change from baseline to 4 weeks)
研究者
Ylva Hellsten
Professor
University of Copenhagen