- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03380481
SouthErn China REgisTry for Stroke on Traditional Chinese Medicine (SECRETS-TCM)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yefeng Cai, M.D.,PhD
- Phone Number: +86-13631333842
- Email: caiyefeng@126.com
Study Contact Backup
- Name: Xinfeng Guo, PhD
- Phone Number: +86-13678906862
- Email: guoxinfeng@gzucm.edu.cn
Study Locations
-
-
Guangdong
-
Jiangmen, Guangdong, China, 529000
- Recruiting
- Wuyi Traditional Chinese Medicine Hospital of Jiangmen
-
Contact:
- Qing Shi, M.D.
- Phone Number: +86 13923082181
- Email: Jmsq27@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SECRETS-TCM
Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China
|
Observational only and no predesigned interventions in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 12 months follow-up
|
12 months follow-up
|
|
Composite cerebrovascular and cardiovascular events
Time Frame: 12 months follow-up
|
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
Time Frame: 24 months follow-up
|
24 months follow-up
|
|
Composite cerebrovascular and cardiovascular events
Time Frame: 24 months follow-up
|
Including stroke recurrence events,acute myocardial infarction and cardiac death
|
24 months follow-up
|
Modified Rankin Scale(mRS)
Time Frame: 3 months follow-up
|
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
|
3 months follow-up
|
Barthel Index(BI)
Time Frame: 3 months follow-up
|
Range:0 to 100 points, higher points represent a better outcome
|
3 months follow-up
|
Mini-Mental State Examination(MMSE)
Time Frame: 3 months follow-up
|
Range:0 to 30 points, higher points represent a better outcome
|
3 months follow-up
|
Modified Rankin Scale(mRS)
Time Frame: 12 months follow-up
|
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
|
12 months follow-up
|
Barthel Index(BI)
Time Frame: 12 months follow-up
|
Range:0 to 100 points, higher points represent a better outcome
|
12 months follow-up
|
Mini-Mental State Examination(MMSE)
Time Frame: 12 months follow-up
|
Range:0 to 30 points, higher points represent a better outcome
|
12 months follow-up
|
Modified Rankin Scale(mRS)
Time Frame: 24 months follow-up
|
Range:Grade 0 to Grade 6, higher grade represent a worse outcome
|
24 months follow-up
|
Barthel Index(BI)
Time Frame: 24 months follow-up
|
Range:0 to 100 points, higher points represent a better outcome
|
24 months follow-up
|
Mini-Mental State Examination(MMSE)
Time Frame: 24 months follow-up
|
Range:0 to 30 points, higher points represent a better outcome
|
24 months follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yefeng Cai, M.D.,Ph D, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Brain Infarction
- Intracranial Hemorrhages
- Infarction
- Stroke
- Ischemic Attack, Transient
- Hemorrhage
- Cerebral Infarction
- Subarachnoid Hemorrhage
- Cerebral Hemorrhage
Other Study ID Numbers
- 201604020003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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