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SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

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状态招聘中
赞助商
Yefeng Cai

关键词

抽象

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).

日期

最后验证: 02/28/2018
首次提交: 12/12/2017
提交的预估入学人数: 12/19/2017
首次发布: 12/20/2017
上次提交的更新: 03/06/2018
最近更新发布: 03/07/2018
实际学习开始日期: 01/14/2018
预计主要完成日期: 12/30/2020
预计完成日期: 12/30/2020

状况或疾病

Stroke
Cerebral Infarction
Transient Ischemic Attack
Cerebral Hemorrhage
Subarachnoid Hemorrhage

干预/治疗

Other: SECRETS-TCM

-

手臂组

干预/治疗
SECRETS-TCM
Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China
Other: SECRETS-TCM
Observational only and no predesigned interventions in this study.

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
取样方式Non-Probability Sample
接受健康志愿者
标准

Inclusion Criteria:

1. ≥18 years.

2. Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).

3. The patient and/or guardian agree to participate in this study.

Exclusion Criteria:

1. Patients with silent cerebrovascular disease.

2. Patients with non-cerebrovascular disease events.

结果

主要结果指标

1. All-cause mortality [12 months follow-up]

2. Composite cerebrovascular and cardiovascular events [12 months follow-up]

Including stroke recurrence events,acute myocardial infarction and cardiac death

次要成果指标

1. All-cause mortality [24 months follow-up]

2. Composite cerebrovascular and cardiovascular events [24 months follow-up]

Including stroke recurrence events,acute myocardial infarction and cardiac death

3. Modified Rankin Scale(mRS) [3 months follow-up]

Range:Grade 0 to Grade 6, higher grade represent a worse outcome

4. Barthel Index(BI) [3 months follow-up]

Range:0 to 100 points, higher points represent a better outcome

5. Mini-Mental State Examination(MMSE) [3 months follow-up]

Range:0 to 30 points, higher points represent a better outcome

6. Modified Rankin Scale(mRS) [12 months follow-up]

Range:Grade 0 to Grade 6, higher grade represent a worse outcome

7. Barthel Index(BI) [12 months follow-up]

Range:0 to 100 points, higher points represent a better outcome

8. Mini-Mental State Examination(MMSE) [12 months follow-up]

Range:0 to 30 points, higher points represent a better outcome

9. Modified Rankin Scale(mRS) [24 months follow-up]

Range:Grade 0 to Grade 6, higher grade represent a worse outcome

10. Barthel Index(BI) [24 months follow-up]

Range:0 to 100 points, higher points represent a better outcome

11. Mini-Mental State Examination(MMSE) [24 months follow-up]

Range:0 to 30 points, higher points represent a better outcome

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