SouthErn China REgisTry for Stroke on Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Composite cerebrovascular and cardiovascular events
研究概览
简要总结
Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years.
In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).
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
- •Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).
- •The patient and/or guardian agree to participate in this study.
排除标准
- •Patients with silent cerebrovascular disease.
- •Patients with non-cerebrovascular disease events.
结局指标
主要结局
Composite cerebrovascular and cardiovascular events
时间窗: 12 months follow-up
Including stroke recurrence events,acute myocardial infarction and cardiac death
All-cause mortality
时间窗: 12 months follow-up
次要结局
- All-cause mortality(24 months follow-up)
- Barthel Index(BI)(24 months follow-up)
- Composite cerebrovascular and cardiovascular events(24 months follow-up)
- Modified Rankin Scale(mRS)(24 months follow-up)
- Mini-Mental State Examination(MMSE)(24 months follow-up)
研究者
Yefeng Cai
Director of Encephalopathy Center of Guangdong Provincial Hospital of Chinese Medcicine
Guangzhou University of Traditional Chinese Medicine