NCT03788512

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2019Dec 2027

First Submitted

Initial submission to the registry

December 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

January 12, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4.9 years

First QC Date

December 25, 2018

Last Update Submit

January 7, 2022

Conditions

Keywords

acute ischemic cerebrovascular diseasecerebral atherosclerosiscoronary atherosclerosiscoexistence

Outcome Measures

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

    1 year

Secondary Outcomes (11)

  • Rate of Major Adverse Cardiovascular Events

    90 days

  • Functional Outcome

    90 days

  • Rate of Ischemic Stroke

    1 year

  • Rate of Acute Coronary Syndrome

    1 year

  • Rate of Cardiovascular Mortality

    1 year

  • +6 more secondary outcomes

Study Arms (1)

AICVD patients with CoCCA

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

Other: observational only- no intervention

Interventions

observational only- no intervention

AICVD patients with CoCCA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, BJ, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

anticoagulant peripheral blood, serum

MeSH Terms

Conditions

Coronary Artery DiseaseIntracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Xin Ma, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 27, 2018

Study Start

January 12, 2019

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2027

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations