SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Stroke Clinical Trial

— SECRETS-TCM  

Official title:

SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03380481
• Other study ID #: 201604020003
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: March 7, 2018
• Start date: January 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2018
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Yefeng Cai, M.D.,PhD
• Phone: +86-13631333842
• Email: caiyefeng[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Infarction
• Hemorrhage
• Infarction
• Ischemic Attack, Transient
• Stroke
• Subarachnoid Hemorrhage
• Transient Ischemic Attack

Intervention

Other:
• observational only-no intervention
Observational only and no predesigned interventions in this study.

Locations

Country	Name	City	State
China	Wuyi Traditional Chinese Medicine Hospital of Jiangmen	Jiangmen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yefeng Cai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		12 months follow-up
Primary	Composite cerebrovascular and cardiovascular events	Including stroke recurrence events,acute myocardial infarction and cardiac death	12 months follow-up
Secondary	All-cause mortality		24 months follow-up
Secondary	Composite cerebrovascular and cardiovascular events	Including stroke recurrence events,acute myocardial infarction and cardiac death	24 months follow-up
Secondary	Modified Rankin Scale(mRS)	Range:Grade 0 to Grade 6, higher grade represent a worse outcome	3 months follow-up
Secondary	Barthel Index(BI)	Range:0 to 100 points, higher points represent a better outcome	3 months follow-up
Secondary	Mini-Mental State Examination(MMSE)	Range:0 to 30 points, higher points represent a better outcome	3 months follow-up
Secondary	Modified Rankin Scale(mRS)	Range:Grade 0 to Grade 6, higher grade represent a worse outcome	12 months follow-up
Secondary	Barthel Index(BI)	Range:0 to 100 points, higher points represent a better outcome	12 months follow-up
Secondary	Mini-Mental State Examination(MMSE)	Range:0 to 30 points, higher points represent a better outcome	12 months follow-up
Secondary	Modified Rankin Scale(mRS)	Range:Grade 0 to Grade 6, higher grade represent a worse outcome	24 months follow-up
Secondary	Barthel Index(BI)	Range:0 to 100 points, higher points represent a better outcome	24 months follow-up
Secondary	Mini-Mental State Examination(MMSE)	Range:0 to 30 points, higher points represent a better outcome	24 months follow-up