SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

• Conditions: Cerebral Hemorrhage; Stroke; Transient Ischemic Attack; Subarachnoid Hemorrhage; Cerebral Infarction
• Interventions: Other: observational only-no intervention

• Registration Number: NCT03380481
• Lead Sponsor: Yefeng Cai

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Study Start: 2018-01-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SECRETS-TCM	observational only-no intervention	Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China

Primary Outcome Measures

Name	Time	Method
Composite cerebrovascular and cardiovascular events	12 months follow-up	Including stroke recurrence events,acute myocardial infarction and cardiac death
All-cause mortality	12 months follow-up

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	24 months follow-up
Barthel Index(BI)	24 months follow-up	Range:0 to 100 points, higher points represent a better outcome
Composite cerebrovascular and cardiovascular events	24 months follow-up	Including stroke recurrence events,acute myocardial infarction and cardiac death
Modified Rankin Scale(mRS)	24 months follow-up	Range:Grade 0 to Grade 6, higher grade represent a worse outcome
Mini-Mental State Examination(MMSE)	24 months follow-up	Range:0 to 30 points, higher points represent a better outcome

Trial Locations

Locations (1)

Wuyi Traditional Chinese Medicine Hospital of Jiangmen; 🇨🇳 Jiangmen, Guangdong, China