China Stroke Registry for Patients With Traditional Chinese Medicine

Ischemic Stroke Clinical Trial

— CASES-TCM  

Official title:

China Stroke Registry for Patients With Traditional Chinese Medicine (CASES-TCM): A Prospective, Multicenter, Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04921397
• Other study ID #: 2021XS-001
• Status: Not yet recruiting
• Start date: June 11, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao
• Phone: +86-10-84013209
• Email: gaoying973[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of patients receive Chinese medicine treatment within 24 hours after admission	Chinese medicine treatment exposure defined as whether patients receive Chinese medicine injection, oral Chinese patent medicine, or compound Chinese medicine.	24 hours after admission
Secondary	Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up	Chinese medicine treatment duration will be assessed using proportion of days covered, which is a percentage of days covered with the medicine in the number of days the patient is eligible to have the medication.	3 months, 12 months, and 24 months follow-up
Secondary	Change in the National Institutes of Health Stroke Scale score between baseline (admission) and discharge	National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	At admission (baseline) and discharge (14 days - mean for length of hospitalization for stroke patients)
Secondary	Patient-Reported Outcomes Scale for Stroke score at discharge	Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst).	At discharge (14 days - mean for length of hospitalization for stroke patients)
Secondary	Proportion of patients with modified Rankin Scale score =2 at 3-month and 12-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, 12 months follow-up
Secondary	Distribution of scores on the modified Rankin scale at 12-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.	12 months follow-up
Secondary	Proportion of patients with Barthel Index score =90 at 3-month and 12-month follow-up	Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).	3 months, 12 months follow-up
Secondary	Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up	Number of patients with new ischemic stroke and hemorrhagic stroke events within 3 months and 24 months of follow-up.	3 months, 24 months follow-up
Secondary	Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up	Number of patients with new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ transient ischemic attack / myocardial infarction /vascular death) within 3 months, 12 months, and 24 months of follow-up.	3 months, 12 months, 24 months follow-up
Secondary	Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up	Mini-Mental State Examination scale is a commonly used scale for measuring the cognitive function. Range: 0 to 30 points, higher points represent a better outcome.	3 months, 12 months, 24 months follow-up
Secondary	All-cause mortality within 12-month and 24-month follow-up	Number of patients who died within 12 months and 24 months of follow-up.	12 months, 24 months follow-up
Secondary	Incidence of adverse events	Number of patients with any adverse events (including serious adverse events) during the study.	Up to 24 months follow-up