Clinical trial NCT03380481: SouthErn China REgisTry for Stroke on Traditional Chinese Medicine
Official title: SouthErn China REgisTry for Stroke on Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Cerebral Infarction
Transient Ischemic Attack
Cerebral Hemorrhage
Subarachnoid Hemorrhage
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months follow-up
measure: Composite cerebrovascular and cardiovascular events
timeFrame: 12 months follow-up
Secondary outcomes:
measure: All-cause mortality
timeFrame: 24 months follow-up
measure: Composite cerebrovascular and cardiovascular events
timeFrame: 24 months follow-up
measure: Modified Rankin Scale(mRS)
timeFrame: 3 months follow-up
measure: Barthel Index(BI)
timeFrame: 3 months follow-up
measure: Mini-Mental State Examination(MMSE)
timeFrame: 3 months follow-up
measure: Modified Rankin Scale(mRS)
timeFrame: 12 months follow-up
measure: Barthel Index(BI)
timeFrame: 12 months follow-up
measure: Mini-Mental State Examination(MMSE)
timeFrame: 12 months follow-up
measure: Modified Rankin Scale(mRS)
timeFrame: 24 months follow-up
measure: Barthel Index(BI)
timeFrame: 24 months follow-up
measure: Mini-Mental State Examination(MMSE)
timeFrame: 24 months follow-up
Other outcomes:
Locations:
city: Jiangmen
country: China
facility: Wuyi Traditional Chinese Medicine Hospital of Jiangmen
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Yefeng Cai, M.D.,Ph D
role: PRINCIPAL_INVESTIGATOR
References: