Coexistence of Cerebral and Coronary AtherosclerosisCoCCANCT03788512
Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
An observational study of Coexistence of Cerebral and Coronary Atherosclerosis and Acute Ischemic Cerebrovascular Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coexistence of Cerebral and Coronary Atherosclerosis, Acute Ischemic Cerebrovascular Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2019to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, BJ, 100053
Xin Ma, MD, PhD, 13501390691, maxin118@hotmail.com
About this study
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.
- Conditions
- Coexistence of Cerebral and Coronary Atherosclerosis, Acute Ischemic Cerebrovascular Disease
- Being tested
- observational only- no intervention
- Keywords
- acute ischemic cerebrovascular disease, cerebral atherosclerosis, coronary atherosclerosis, coexistence
- Medical subject headings
- Coronary Artery Disease, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only- no interventionOther
observational only- no intervention
| Study group | Role | What they receive |
|---|---|---|
| AICVD patients with CoCCA | acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis. Receives: Other: observational only- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (11)
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
Measured: 90 days
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.
Measured: 90 days
Rate of Ischemic Stroke
fatal and nonfatal ischemic stroke.
Measured: 1 year
Rate of Acute Coronary Syndrome
fatal and nonfatal myocardial infarction and unstable angina
Measured: 1 year
Rate of Cardiovascular Mortality
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Measured: 1 year
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
Measured: 5 years
Time to First Ischemic Stroke
from the date of enrollment until the date of first documented ischemic stroke, assessed up to 5 years
Measured: 5 years
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
Measured: 5 years
Rate of Ischemic Stroke
fatal and nonfatal ischemic stroke
Measured: 5 years
Rate of Acute Coronary Syndrome
fatal and nonfatal myocardial infarction and unstable angina
Measured: 5 years
Rate of Cardiovascular Mortality
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start12 Jan 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coexistence of Cerebral and Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Ma, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788512
- Sponsor's protocol ID
- CoCCA
- Acronym
- CoCCA
- Status last verified
- Jan 2022
- First submitted
- 25 Dec 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coexistence of Cerebral and Coronary Atherosclerosis in Acute Ischemic Cerebrovascular Disease Patients Registry
- ClinicalTrials.gov ID
- NCT03788512
- Acronym / sponsor ID
- CoCCA / CoCCA
- Conditions
- Coexistence of Cerebral and Coronary Atherosclerosis, Acute Ischemic Cerebrovascular Disease
- Keywords
- acute ischemic cerebrovascular disease, cerebral atherosclerosis, coronary atherosclerosis, coexistence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AICVD patients with CoCCA | – | Other: observational only- no interventionacute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute ischemic cerebrovascular disease patients with coexistence of cerebral and coronary atherosclerosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only- no interventionobservational only- no intervention | Other | AICVD patients with CoCCA |
Primary outcome
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
11 secondary outcomes
Rate of Major Adverse Cardiovascular Events
Time frame: 90 days
Functional Outcome
Time frame: 90 days
Rate of Ischemic Stroke
Time frame: 1 year
Rate of Acute Coronary Syndrome
Time frame: 1 year
Rate of Cardiovascular Mortality
Time frame: 1 year
Time to First Major Adverse Cardiovascular Event
Time frame: 5 years
Time to First Ischemic Stroke
Time frame: 5 years
Rate of Major Adverse Cardiovascular Events
Time frame: 5 years
Rate of Ischemic Stroke
Time frame: 5 years
Rate of Acute Coronary Syndrome
Time frame: 5 years
Rate of Cardiovascular Mortality
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coexistence of Cerebral and Coronary Atherosclerosis and Acute Ischemic Cerebrovascular Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Ma, MD, PhD (13501390691, maxin118@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Cardiovascular Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.