China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): A Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up
研究概览
简要总结
The CASES-TCM study is a prospective, multicenter, observational study, which will enroll 20,000 patients with acute stroke (ischemic stroke or intracerebral hemorrhage) within 7 days of symptom onset.
This study attempts to depict major clinical characteristics of acute stroke in patients with Chinese medicine treatment and to explore any difference compared with other non-Chinese medicine use cohorts and the effectiveness and safety of Chinese medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •≥18 years of age
- •Diagnosed as acute ischemic stroke or intracerebral hemorrhage
- •Within 7 days of symptom onset
排除标准
- •Refusal to give informed consent
- •Have difficulties completing follow-up
结局指标
主要结局
Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up
时间窗: 12 months follow-up
Number of patients with new ischemic stroke and hemorrhagic stroke within 12 months of follow-up.
Distribution of scores on the modified Rankin scale at 3-month follow-up
时间窗: 3 months follow-up
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
次要结局
- Proportion of patients receive Chinese medicine treatment within 24 hours after admission(24 hours after admission)
- Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up(3 months, 12 months, and 24 months follow-up)
- Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge(At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients))
- Patient-Reported Outcomes Scale for Stroke score at discharge(At discharge (14 days - mean for length of hospitalization for stroke patients))
- Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up(3 months, 12 months follow-up)
- Proportion of patients with Barthel Index score ≥90 at 3-month and 12-month follow-up(3 months, 12 months follow-up)
- Distribution of scores on the modified Rankin scale at 12-month follow-up(12 months follow-up)
- Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up(3 months, 24 months follow-up)
- Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up(3 months, 12 months, 24 months follow-up)
- Incidence of adverse events(Up to 24 months follow-up)
- Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up(3 months, 12 months, 24 months follow-up)
- All-cause mortality within 12-month and 24-month follow-up(12 months, 24 months follow-up)
研究者
Ying Gao
President of Institute for Brain Disorders, Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing