The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,875
- 试验地点
- 1
- 主要终点
- all cerebral bleeding events
研究概览
简要总结
The purpose of this prospective cohort study is to investigate whether antithrombotic therapy in the secondary prevention of ischemic stroke increases the risk of the emerging CMBs and whether the change is associated with an increased risk of intracranial hemorrhage, providing an imaging evidence for individualized antithrombotic therapy in such patients.
详细描述
Cerebral microbleeds（CMBs） is a subclinical lesion caused by microvascular disease in the brain, characterized by microleakage of blood. About 30% of ischemic stroke patients, 40% of the healthy people over 80 years old, and 60% of intracranial hemorrhage patients have microbleeds. With the development of imaging technology, clinically more and more patients have found microbleeds in the brain. How these patients are treated with antithrombotic drugs is not yet clear and is in urgent need of evidence. There are only a few prospective cohort studies to determine whether antithrombotic therapy increases the risk of intracranial hemorrhage in ischemic stroke patients with CMBs, but the results are uncertain. More importantly, whether antithrombotic therapy increases the incidence of the emerging CMBs, and whether the change of increased microbleeds is associated with increased intracranial hemorrhage has not been reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient age ≥18 years;
- •Acute ischemic stroke patient confirmed by imaging;
- •Time of onset: within 3 months;
- •Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke;
- •Baseline SWI sequence must have at least one CMB ;
排除标准
- •MRI contraindication;
- •Hemorrhagic transformation after acute Ischemic stroke;
- •Contraindication for antiplatelet or anticoagulation therapy;
- •Severe head trauma or intracranial hemorrhage occurred in the past six months;
- •obvious coagulopathy;
- •Other intracranial lesions associated with (such as tumor, cerebral vascular malformation);
- •other unqualified patients judged by the investigator
结局指标
主要结局
all cerebral bleeding events
时间窗: 360 days
incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
次要结局
- proportion of cerebral microbleeds(180 、360 days)
- all cerebral bleeding events(180 days)
- proportion of mRS 0-1.(180、360 days)
- proportion of cerebral hemorrhage(180、360 days)
- the occurence of stroke or other vascular events(180、360 days)
- the occurence of death due to any cause(180、360 days)
研究者
Hui-Sheng Chen
Director of neurological department
General Hospital of Shenyang Military Region