Clinical trial NCT03788512: Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
Official title: Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coexistence of Cerebral and Coronary Atherosclerosis
Acute Ischemic Cerebrovascular Disease
Keywords: acute ischemic cerebrovascular disease
cerebral atherosclerosis
coronary atherosclerosis
coexistence
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 1 year
Secondary outcomes:
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 90 days
measure: Functional Outcome
timeFrame: 90 days
measure: Rate of Ischemic Stroke
timeFrame: 1 year
measure: Rate of Acute Coronary Syndrome
timeFrame: 1 year
measure: Rate of Cardiovascular Mortality
timeFrame: 1 year
measure: Time to First Major Adverse Cardiovascular Event
timeFrame: 5 years
measure: Time to First Ischemic Stroke
timeFrame: 5 years
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 5 years
measure: Rate of Ischemic Stroke
timeFrame: 5 years
measure: Rate of Acute Coronary Syndrome
timeFrame: 5 years
measure: Rate of Cardiovascular Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: