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: Unknown
• Conditions: Stroke; Transient Ischemic Attack; Cerebral Infarction; Subarachnoid Hemorrhage; Cerebral Hemorrhage
• Intervention / Treatment: Other: observational only-no intervention

• Study Type: Observational
• Enrollment (Anticipated): 10000

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

• China
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Yefeng Cai
• 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): January 15, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

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: No
• Studies a U.S. FDA-regulated device product: No