SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Conditions
-----------------
Stroke, Cerebral Infarction, Transient Ischemic Attack, Cerebral Hemorrhage, Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Other: observational only-no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years. 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. Exclusion Criteria: Patients with silent cerebrovascular disease. Patients with non-cerebrovascular disease events.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SECRETS-TCM<br>Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China | Other: observational only-no intervention<br>* Observational only and no predesigned interventions in this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |