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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT03788512
Collaborator
(none)
500
1
106.6
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
Actual Study Start Date :
Jan 12, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Rate of Major Adverse Cardiovascular Events [90 days]

    cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina

  2. 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.

  3. Rate of Ischemic Stroke [1 year]

    fatal and nonfatal ischemic stroke.

  4. Rate of Acute Coronary Syndrome [1 year]

    fatal and nonfatal myocardial infarction and unstable angina

  5. Rate of Cardiovascular Mortality [1 year]

    any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death

  6. 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

  7. 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

  8. 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

  9. Rate of Ischemic Stroke [5 years]

    fatal and nonfatal ischemic stroke

  10. Rate of Acute Coronary Syndrome [5 years]

    fatal and nonfatal myocardial infarction and unstable angina

  11. Rate of Cardiovascular Mortality [5 years]

    any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xuanwu Hospital, Capital Medical University Beijing Beijing China 100053

Sponsors and Collaborators

  • Xuanwu Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xin Ma, Principal investigator, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT03788512
Other Study ID Numbers:
  • CoCCA
First Posted:
Dec 27, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xin Ma, Principal investigator, Xuanwu Hospital, Beijing
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022