Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry

Recruiting

• Conditions: Coexistence of Cerebral and Coronary Atherosclerosis; Acute Ischemic Cerebrovascular Disease
• Interventions: Other: observational only- no intervention

• Registration Number: NCT03788512
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

Atherosclerosis has exerted huge global burden as the common pathological process underlying ischemic heart disease and cerebrovascular disease. A substantial portion of acute ischemic cerebrovascular disease (AICVD) patients have both cerebral and coronary atherosclerosis, which is an omen of poor outcomes. But there is large evidence gap in these high-risk patients' prognosis-related factors, limiting the improvement of care quality.

Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry (CoCCA) is a single-center prospective observational registry of patients hospitalized for 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.

The clinical, imaging and laboratory information will be collected at the baseline. During an estimated 5-year follow-up, the vessel-related diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits.

Study Timeline

• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-27
• Study Start: 2019-01-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AICVD patients with CoCCA	observational only- no intervention	acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis.

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Cardiovascular Events	1 year	cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina

Secondary Outcome Measures

Name	Time	Method
Rate of Acute Coronary Syndrome	5 years	fatal and nonfatal myocardial infarction and unstable angina
Functional Outcome	90 days	Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.
Time to First Major Adverse Cardiovascular Event	5 years	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
Rate of Major Adverse Cardiovascular Events	5 years	cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
Rate of Ischemic Stroke	5 years	fatal and nonfatal ischemic stroke
Rate of Cardiovascular Mortality	5 years	any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Time to First Ischemic Stroke	5 years	from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China