A Random Controlled, Double-Blind Clinical Trial: Remote Ischemic Preconditioning and Cerebral Small Vessel Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- changes in brain lesions
研究概览
简要总结
The hypothesis of this study is that remote ischemic preconditioning (RIPC) might have a beneficial effect on outcomes of cerebral small vessel disease (CSV).
详细描述
CSV constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. Few treatment methods are available except some beneficial effect shown with nimodipine. The potential treatment effect of RIPC on protection of brain from cerebral small vessel disease has not been investigated. The investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether RIPC has a beneficial effect on brain lesions of CSV, and (2) whether RIPC can protect patients of CSV from cognitive deterioration. There are 2 arms in this trial: One arm is RIPC treatment, the other one is sham RIPC treatment. Brain lesions will be quantified by volumetric MRI, and Xe-CT will be used to evaluate cerebral blood perfusion. Cognitive function will be evaluated by mini-mental state examination (MMSE) and the Montreal Cognitive Assessment (MoCA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 40-80 years;
- •Ischemic cerebrovascular event onset, if any, must be within 6 months;
- •TCD and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually >50% narrow lumen);
- •MRI confirmed the presence of lacunar infarction and / or generalized white matter lesions;
- •Written consent was obtained from the subject.
排除标准
- •History of intracranial hemorrhage;
- •Significant bleeding from other parts of the body;
- •History of atrial fibrillation;
- •History of myocardial infarction within six months;
- •Moyamoya disease or vasculitis;
- •Hereditary small vessel disorders, such as CADASIL, FABRY, and mitochondrial encephalo-myopathy;
- •Significant bleeding-coagulation dysfunction;
- •Abnormal blood pressure, glucose and/or lipids after restrict treatment regimen;
- •Severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.
结局指标
主要结局
changes in brain lesions
时间窗: 0-24 months
Volumetric MRI will be used for calculating changes in the number of lacunar infarctions and the total volume of white matter lesions
次要结局
- Changes in the cognitive function(0-24 months)
- Changes in the cerebral blood perfusion(0-24 months)
研究者
Ji Xunming
Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
Capital Medical University