Coronary Artery DiseaseNCT06036901
Asan Medical Center CCTA Registry
An observational study of Coronary Artery Disease and Risk Factor, run by CardioVascular Research Foundation, Korea.
Trial summary
A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Risk Factor, Computed Tomography
- What is being tested?
- Coronary CT
- How many people
- 6,343 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 31 Dec 2022
- How long will I take part?
- 10 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 20 years and older had undergone self-referral CCTA evaluation as part of a general health examination in the Health Screening and Promotion Center at Asan Medical Center from January 2007 to December 2011.
Who may be able to join
None listed.
Who cannot join
- a previous history of angina or myocardial infarction;
- abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST segments or T wave changes, or left bundle-branch blocks;
- insufficient medical records;
- structural heart diseases;
- a prior history of open heart surgery or percutaneous coronary intervention;
- a previous cardiac procedure; or
- renal insufficiency (creatinine N1.5 mg/dL)
About this study
Official title: Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study
A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. All participants were provided with information about the potential benefits and risks of CCTA and made the decision to undergo the procedure at their own expense. They were also informed that their clinical and radiological data would be used for this study and gave their consent. Of these individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.
- Conditions
- Coronary Artery Disease, Risk Factor, Computed Tomography
- Being tested
- Coronary CT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CTDiagnostic test
Coronary CT evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of CAD
Diameter stenosis >50% in any coronary artery by coronary CT angiography
Measured: 5 years
Secondary outcomes (4)
All cause mortality
Measured: 5 years
cardiovascular mortality
any death caused by a cardiovascular problem or if there was no identified cause of death
Measured: 5 years
myocardial infarction
Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.
Measured: 5 years
Revascularization
Number of participants with any percutaneous or surgical revascularization procedure during follow-up.
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 posted14 Sep 2023
- Study start1 Jan 2007
- Primary completion31 Dec 2011
- Study completion31 Dec 2022
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.
- 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
- 6,343 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- CardioVascular Research Foundation, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Whan Lee, CardioVascular Research Foundation, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036901
- Sponsor's protocol ID
- CardioVascularRF
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06036901
- Acronym / sponsor ID
- CardioVascularRF
- Conditions
- Coronary Artery Disease, Risk Factor, Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,343 participants (actual)
- Lead sponsor
- CardioVascular Research Foundation, KoreaUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Sep 2023 (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.
A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. All participants were provided with information about the potential benefits and risks of CCTA and made the decision to undergo the procedure at their own expense. They were also informed that their clinical and radiological data would be used for this study and gave their consent. Of these individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 20 years and older had undergone self-referral CCTA evaluation as part of a general health examination in the Health Screening and Promotion Center at Asan Medical Center from January 2007 to December 2011.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- a previous history of angina or myocardial infarction;
- abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST segments or T wave changes, or left bundle-branch blocks;
- insufficient medical records;
- structural heart diseases;
- a prior history of open heart surgery or percutaneous coronary intervention;
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 |
|---|---|---|
| Coronary CTCoronary CT evaluation | Diagnostic test | – |
Primary outcome
The prevalence of CAD
Time frame: 5 years
Diameter stenosis >50% in any coronary artery by coronary CT angiography
4 secondary outcomes
All cause mortality
Time frame: 5 years
cardiovascular mortality
Time frame: 5 years
myocardial infarction
Time frame: 5 years
Revascularization
Time frame: 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 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Risk Factor, run by CardioVascular Research Foundation, 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 0 inclusion and 7 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The prevalence of CAD (time frame: 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 14 Sep 2023.