China Stroke Registry for Patients With Traditional Chinese Medicine

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke, Intracerebral Hemorrhage

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Incidence of adverse events | Number of patients with any adverse events (including serious adverse events) during the study. | Up to 24 months follow-up |