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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SECRETS-TCM | Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational only-no intervention | Other | Observational only and no predesigned interventions in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 12 months follow-up | |
| Composite cerebrovascular and cardiovascular events | Including stroke recurrence events,acute myocardial infarction and cardiac death | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 24 months follow-up | |
| Composite cerebrovascular and cardiovascular events | Including stroke recurrence events,acute myocardial infarction and cardiac death | 24 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be comprised of those who meet all inclusion criteria and no exclusion criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 10000 is reached. This study will be conducted in more than 50 hopitals in southern China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yefeng Cai, M.D.,PhD | Contact | +86-13631333842 | caiyefeng@126.com | |
| Xinfeng Guo, PhD | Contact | +86-13678906862 | guoxinfeng@gzucm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yefeng Cai, M.D.,Ph D | Guangdong Provincial Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuyi Traditional Chinese Medicine Hospital of Jiangmen | Recruiting | Jiangmen | Guangdong | 529000 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002544 | Cerebral Infarction |
| D002546 | Ischemic Attack, Transient |
| D002543 | Cerebral Hemorrhage |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Modified Rankin Scale(mRS) | Range:Grade 0 to Grade 6, higher grade represent a worse outcome | 3 months follow-up |
| Barthel Index(BI) | Range:0 to 100 points, higher points represent a better outcome | 3 months follow-up |
| Mini-Mental State Examination(MMSE) | Range:0 to 30 points, higher points represent a better outcome | 3 months follow-up |
| Modified Rankin Scale(mRS) | Range:Grade 0 to Grade 6, higher grade represent a worse outcome | 12 months follow-up |
| Barthel Index(BI) | Range:0 to 100 points, higher points represent a better outcome | 12 months follow-up |
| Mini-Mental State Examination(MMSE) | Range:0 to 30 points, higher points represent a better outcome | 12 months follow-up |
| Modified Rankin Scale(mRS) | Range:Grade 0 to Grade 6, higher grade represent a worse outcome | 24 months follow-up |
| Barthel Index(BI) | Range:0 to 100 points, higher points represent a better outcome | 24 months follow-up |
| Mini-Mental State Examination(MMSE) | Range:0 to 30 points, higher points represent a better outcome | 24 months follow-up |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |