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NCT Number: NCT03788512

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as ischemic stroke or transient ischemic attack (TIA).
  • Less than 30 days after onset of ischemic stroke or TIA symptoms.
  • Extracranial or intracranial cerebral atherosclerosis confirmed by vascular ultrasound or CT angiograpgy or MR angiograpgy or digital substraction angiography.
  • 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

  • With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 5 years.
  • Patients refuse to participate in the research.

Treatment and study plan

observational only- no intervention

Other

observational only- no intervention

Primary outcomes

  1. Rate of Major Adverse Cardiovascular Events

    Time frame: 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 outcomes

  1. Rate of Major Adverse Cardiovascular Events

    Time frame: 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

    Time frame: 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

    Time frame: 1 year

    fatal and nonfatal ischemic stroke.

  4. Rate of Acute Coronary Syndrome

    Time frame: 1 year

    fatal and nonfatal myocardial infarction and unstable angina

  5. Rate of Cardiovascular Mortality

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 5 years

    fatal and nonfatal ischemic stroke

  10. Rate of Acute Coronary Syndrome

    Time frame: 5 years

    fatal and nonfatal myocardial infarction and unstable angina

  11. Rate of Cardiovascular Mortality

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Ma, MD, PhD

CONTACT

[email protected]

13501390691

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Acronym: CoCCA

Important dates

Study start
2019
Primary completion
2023
Study completion
2027
First posted
Dec 27, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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