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

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.

Study Overview

• Status: Recruiting
• Conditions: Coexistence of Cerebral and Coronary Atherosclerosis; Acute Ischemic Cerebrovascular Disease
• Intervention / Treatment: Other: observational only- no intervention

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AICVD patients with CoCCA; acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis.	Other: observational only- no intervention; observational only- no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rate of Ischemic Stroke	fatal and nonfatal ischemic stroke.	1 year
Rate of Acute Coronary Syndrome	fatal and nonfatal myocardial infarction and unstable angina	1 year
Rate of Cardiovascular Mortality	any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death	1 year
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
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
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
Rate of Ischemic Stroke	fatal and nonfatal ischemic stroke	5 years
Rate of Acute Coronary Syndrome	fatal and nonfatal myocardial infarction and unstable angina	5 years
Rate of Cardiovascular Mortality	any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death	5 years

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2019
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2027

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (ACTUAL): December 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: coronary atherosclerosis; acute ischemic cerebrovascular disease; cerebral atherosclerosis; coexistence
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Atherosclerosis; Cerebrovascular Disorders
• Other Study ID Numbers: CoCCA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No