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RecruitingNCT03788512CoCCAUpdated Jan 11, 2022

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

An observational study in Coexistence of Cerebral and Coronary Atherosclerosis and Acute Ischemic Cerebrovascular Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coexistence of Cerebral and Coronary Atherosclerosis
  • Acute Ischemic Cerebrovascular Disease

Keywords

  • acute ischemic cerebrovascular disease
  • cerebral atherosclerosis
  • coronary atherosclerosis
  • coexistence
03

In context

Cerebrovascular Disorders

374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's planned enrollment of 500 is above the median of 443 across 135 observational studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • AICVD patients with CoCCA

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

    Other: observational only- no intervention

Interventions

  • Otherobservational only- no intervention

    observational only- no intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 90 days

  2. 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.

    Time frame: 90 days

  3. Rate of Ischemic Stroke

    fatal and nonfatal ischemic stroke.

    Time frame: 1 year

  4. Rate of Acute Coronary Syndrome

    fatal and nonfatal myocardial infarction and unstable angina

    Time frame: 1 year

  5. Rate of Cardiovascular Mortality

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

    Time frame: 1 year

  6. 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

    Time frame: 5 years

  7. Time to First Ischemic Stroke

    from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years

    Time frame: 5 years

  8. 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

    Time frame: 5 years

  9. Rate of Ischemic Stroke

    fatal and nonfatal ischemic stroke

    Time frame: 5 years

  10. Rate of Acute Coronary Syndrome

    fatal and nonfatal myocardial infarction and unstable angina

    Time frame: 5 years

  11. Rate of Cardiovascular Mortality

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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, Beijing 100053, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03788512
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Xin Ma (Principal investigator, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Dec 27, 2018
Start date
Jan 12, 2019
Primary completion
Dec 2023 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 11, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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