Intracerebral Hemorrhage, Ischemic Stroke
Conditions
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.
Interventions
None listed
Sponsors
Dongzhimen Hospital, Beijing
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of scores on the modified Rankin scale at 3-month follow-up | 3 months 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. |
| Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 12-month follow-up | 12 months follow-up | Number of patients with new ischemic stroke and hemorrhagic stroke within 12 months of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Patient-Reported Outcomes Scale for Stroke score at discharge | At discharge (14 days - mean for length of hospitalization for stroke patients) | 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). |
| Proportion of patients with modified Rankin Scale score ≤2 at 3-month and 12-month follow-up | 3 months, 12 months 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. |
| Distribution of scores on the modified Rankin scale at 12-month follow-up | 12 months 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. |
| Proportion of patients with Barthel Index score ≥90 at 3-month and 12-month follow-up | 3 months, 12 months 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). |
| Proportion of patients receive Chinese medicine treatment within 24 hours after admission | 24 hours after admission | Chinese medicine treatment exposure defined as whether patients receive Chinese medicine injection, oral Chinese patent medicine, or compound Chinese medicine. |
| Composite of new clinical vascular events within 3-month, 12-month, and 24-month follow-up | 3 months, 12 months, 24 months 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. |
| Mini-Mental State Examination scale score at 3-month, 12-month, and 24-month follow-up | 3 months, 12 months, 24 months 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. |
| All-cause mortality within 12-month and 24-month follow-up | 12 months, 24 months follow-up | Number of patients who died within 12 months and 24 months of follow-up. |
| Incidence of adverse events | Up to 24 months follow-up | Number of patients with any adverse events (including serious adverse events) during the study. |
| Recurrent stroke events (ischemic stroke, hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage) within 3-month and 24-month follow-up | 3 months, 24 months follow-up | Number of patients with new ischemic stroke and hemorrhagic stroke events within 3 months and 24 months of follow-up. |
| Chinese medicine treatment duration within 3-month, 12-month, and 24-month follow-up | 3 months, 12 months, and 24 months 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. |
Countries
China
Contacts
Primary ContactYing Gao
Outcome results
None listed