Coronary Artery DiseaseACADISNCT01850693
Assessment of Coronary Artery Disease in Stroke Patients
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 1,657 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2006to Jun 2015
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients on the basis of TOAST classification
Who may be able to join
- Acute stroke patients who diagnosed by clinical and brain MR imaging
- Who performed coronary CT angiography within 3 months after acute stroke
Who cannot join
- intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage
- brain tumor
- Previous myocardial infarction
- Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
- Insufficient medical record
- Poor image quality of CCTA scan
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 436-707
About this study
Official title: Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography
This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.
Read the detailed description
Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.
Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.
Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, stroke, coronary CT angiography
- Medical subject headings
- Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease, Stroke | Coronary artery disease, stroke, coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Adverse Cardiac Event)
MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization
Measured: Participants will be followed until June. 2015, an expeded average of 5 years
Secondary outcomes (1)
Any cardiac events
- late revascularization: who underwent revascularization therapy mroe than 90days after CCTA and referral due ot new symptoms or an abnormal function test, 2) heart failure required hospitalization.
Measured: Participants will be followed until June. 2015, an expeded average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJul 2006
- Primary completionDec 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Enrolment
- 1,657 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
- Investigators
- Eun Ju Chun, MD, Principal investigator, Department of Radiology, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850693
- Sponsor's protocol ID
- NRF 2010-0023504
- Acronym
- ACADIS
- Status last verified
- May 2013
- First submitted
- 3 May 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT01850693
- Acronym / sponsor ID
- ACADIS / NRF 2010-0023504
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, stroke, coronary CT angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,657 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- Jul 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 May 2013 (estimated)
- 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.
This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.
Detailed description
Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.
Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.
Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.
Study design
- Observational model
- Cohort
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease, Stroke | – | –Coronary artery disease, stroke, coronary CT angiography |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients on the basis of TOAST classification
Key inclusion criteria (2 listed)
- Acute stroke patients who diagnosed by clinical and brain MR imaging
- Who performed coronary CT angiography within 3 months after acute stroke
Key exclusion criteria (6 listed)
- intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage
- brain tumor
- Previous myocardial infarction
- Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
- Insufficient medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE (Major Adverse Cardiac Event)
Time frame: Participants will be followed until June. 2015, an expeded average of 5 years
MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization
1 secondary outcome
Any cardiac events
Time frame: Participants will be followed until June. 2015, an expeded average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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. This study is not recruiting at the moment.
Eun Ju Chun, MD principal investigator
Department of Radiology, Seoul National University Bundang Hospital
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 Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 10 Nov 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (Major Adverse Cardiac Event) (time frame: Participants will be followed until June. 2015, an expeded average of 5 years). 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 10 Nov 2015.