Acute Ischemic Cerebrovascular Disease Clinical Trial
— CoCCAOfficial title:
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
| NCT number | NCT03788512 |
| Other study ID # | CoCCA |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 12, 2019 |
| Est. completion date | December 2027 |
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center observational registry of patients hospitalized for acute ischemic cerebrovascular disease (AICVD) with atherosclerotic changes in both cerebral and coronary arteries. This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | December 2027 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: 1. Diagnosed as ischemic stroke or transient ischemic attack (TIA). 2. Less than 30 days after onset of ischemic stroke or TIA symptoms. 3. Extracranial or intracranial cerebral atherosclerosis confirmed by vascular ultrasound or CT angiograpgy or MR angiograpgy or digital substraction angiography. 4. Coronary atherosclerosis confirmed by CT angiograpgy or MR angiograpgy or digital substraction angiography; or with myocardial ischemia symptoms confirmed using electrocardiogram or echocardiography or cardiac MR; or with a history of percutaneous coronary intervention or coronary artery bypass graft. Exclusion Criteria: 1. With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 5 years. 2. Patients refuse to participate in the research. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xuanwu Hospital, Capital Medical University | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Xuanwu Hospital, Beijing |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of Major Adverse Cardiovascular Events | cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina | 1 year | |
| Secondary | Rate of Major Adverse Cardiovascular Events | cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina | 90 days | |
| Secondary | Functional Outcome | Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled. | 90 days | |
| Secondary | Rate of Ischemic Stroke | fatal and nonfatal ischemic stroke. | 1 year | |
| Secondary | Rate of Acute Coronary Syndrome | fatal and nonfatal myocardial infarction and unstable angina | 1 year | |
| Secondary | Rate of Cardiovascular Mortality | any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death | 1 year | |
| Secondary | Time to First Major Adverse Cardiovascular Event | from the date of enrollment until the date of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina, whichever comes first, assessed up to 5 years | 5 years | |
| Secondary | Time to First Ischemic Stroke | from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years | 5 years | |
| Secondary | Rate of Major Adverse Cardiovascular Events | cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina | 5 years | |
| Secondary | Rate of Ischemic Stroke | fatal and nonfatal ischemic stroke | 5 years | |
| Secondary | Rate of Acute Coronary Syndrome | fatal and nonfatal myocardial infarction and unstable angina | 5 years | |
| Secondary | Rate of Cardiovascular Mortality | any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death | 5 years |