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

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ClinicalTrials.gov Identifier: NCT03788512
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Xin Ma, Xuanwu Hospital, Beijing

Study Description
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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
Coexistence of Cerebral and Coronary Atherosclerosis Acute Ischemic Cerebrovascular Disease 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
Actual Study Start Date : January 12, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
anticoagulant peripheral blood, serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788512


Contacts
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Contact: Xin Ma, MD, PhD 13501390691 maxin118@hotmail.com

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Xin Ma, MD, PhD    13501390691    maxin118@hotmail.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
More Information
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Additional Information:

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Responsible Party: Xin Ma, Principal investigator, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03788512    
Other Study ID Numbers: CoCCA
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Ma, Xuanwu Hospital, Beijing:
acute ischemic cerebrovascular disease
cerebral atherosclerosis
coronary atherosclerosis
coexistence
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases