Clinical trial NCT04921397: China Stroke Registry for Patients With Traditional Chinese Medicine
Official title: China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): A Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Intracerebral Hemorrhage
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the criteria will be consecutively enrolled from 100 participating sites in China.

Brief summary: The CASES-TCM study is a prospective, multicenter, observational study, which will enroll 20,000 patients with acute stroke (ischemic stroke or intracerebral hemorrhage) within 7 days of symptom onset.

This study attempts to depict major clinical characteristics of acute stroke in patients with Chinese medicine treatment and to explore any difference compared with other non-Chinese medicine use cohorts and the effectiveness and safety of Chinese medicine.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Diagnosed as acute ischemic stroke or intracerebral hemorrhage
* Within 7 days of symptom onset

Exclusion Criteria:

* Refusal to give informed consent
* Have difficulties completing follow-up

Primary outcomes:
measure: Distribution of scores on the modified Rankin scale at 3-month follow-up
timeFrame: 3 months follow-up
measure: Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Proportion of patients receive Chinese medicine treatment within 24 hours after admission
timeFrame: 24 hours after admission
measure: Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up
timeFrame: 3 months, 12 months, and 24 months follow-up
measure: Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge
timeFrame: At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients)
measure: Patient-Reported Outcomes Scale for Stroke score at discharge
timeFrame: At discharge (14 days - mean for length of hospitalization for stroke patients)
measure: Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up
timeFrame: 3 months, 12 months follow-up
measure: Distribution of scores on the modified Rankin scale at 12-month follow-up
timeFrame: 12 months follow-up
measure: Proportion of patients with Barthel Index score ≥90 at 3-month and 12-month follow-up
timeFrame: 3 months, 12 months follow-up
measure: Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up
timeFrame: 3 months, 24 months follow-up
measure: Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up
timeFrame: 3 months, 12 months, 24 months follow-up
measure: Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up
timeFrame: 3 months, 12 months, 24 months follow-up
measure: All-cause mortality within 12-month and 24-month follow-up
timeFrame: 12 months, 24 months follow-up
measure: Incidence of adverse events
timeFrame: Up to 24 months follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Ying Gao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng L, Kong L, Dong X, Lai X, Zhang D, Ren B, Liu S, Xie X, Li C, Song Y, Du Y, Cao K, Zhang C, Gao Y; CASES-TCM Protocol Steering Group. China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): Rationale and Design of a Prospective, Multicenter, Observational Study. Front Pharmacol. 2021 Aug 31;12:743883. doi: 10.3389/fphar.2021.743883. eCollection 2021.