China Stroke Registry for Patients With Traditional Chinese Medicine

NCT04921397 | Unknown DMC

• 1 other identifier: 2021XS-001
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Distribution of scores on the modified Rankin scale at 3-month follow-up

  Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 -No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.

  3 months follow-up

• Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up

  Number of patients with new ischemic stroke and hemorrhagic stroke within 12 months of follow-up.

  12 months follow-up

Secondary Outcomes (12)

• Proportion of patients receive Chinese medicine treatment within 24 hours after admission

  24 hours after admission

• Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up

  3 months, 12 months, and 24 months follow-up

• Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge

  At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients)

• Patient-Reported Outcomes Scale for Stroke score at discharge

  At discharge (14 days - mean for length of hospitalization for stroke patients)

• Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up

  3 months, 12 months follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the criteria will be consecutively enrolled from 100 participating sites in China.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (1)

• 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.

  PMID: 34531755 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Gao

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Gao

CONTACT

+86-10-84013209; gaoying973@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Institute for Brain Disorders, Beijing University of Chinese Medicine

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 10, 2021
• Study Start: June 11, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 1, 2025
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)