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

Acute Ischemic Cerebrovascular Disease Clinical Trial

— CoCCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788512
• Other study ID #: CoCCA
• Status: Recruiting
• Start date: January 12, 2019
• Est. completion date: December 2027

Study information

• Verified date: January 2022
• Source: Xuanwu Hospital, Beijing
• Contact: Xin Ma, MD, PhD
• Phone: 13501390691
• Email: maxin118[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Ischemic Cerebrovascular Disease
• Atherosclerosis
• Cerebrovascular Disorders
• Coexistence of Cerebral and Coronary Atherosclerosis
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Other:
• observational only- no intervention
observational only- no intervention

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

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