Cardiovascular DiseasesKAS3NCT01168362
Korea Atherosclerosis Study-3
An observational study of Cardiovascular Diseases and Cardiovascular Mortality, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Mortality, All-cause Mortality
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to May 2013
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: positive cardiovascular risks or not
Who may be able to join
- Korean capable of Multidetector-Row Cardiac Computed Tomography (MDCT)
Who cannot join
- malignancy
- infection
- shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Coronary Artery Disease With Multidetector-Row Cardiac Computed Tomography in Positive Cardiovascular Risk or Not
Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Especially,the investigators will evaluate the relationships between the pericardial fat and severity of stenosis as well as plaque characteristics using logistic regression models.
- Keywords
- coronary artery disease, cardiovascular risk, pericardial fat
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
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 |
|---|---|---|
| High risk group | positive cardiovascular risk group | |
| Low risk group | negative cardiovascular risk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of coronary artery disease
Measured: 5 years
Secondary outcomes (1)
Mortality
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 posted23 Jul 2010 (estimated)
- Study startFeb 2006
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD,PHD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168362
- Sponsor's protocol ID
- M10642140004-06N4214
- Acronym
- KAS3
- Status last verified
- Oct 2013
- First submitted
- 22 Jul 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Coronary Artery Disease With Multidetector-Row Cardiac Computed Tomography in Positive Cardiovascular Risk or Not
- ClinicalTrials.gov ID
- NCT01168362
- Acronym / sponsor ID
- KAS3 / M10642140004-06N4214
- Keywords
- coronary artery disease, cardiovascular risk, pericardial fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jul 2010 (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.
Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Especially,the investigators will evaluate the relationships between the pericardial fat and severity of stenosis as well as plaque characteristics using logistic regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk group | – | –positive cardiovascular risk group |
| Low risk group | – | –negative cardiovascular risk group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- positive cardiovascular risks or not
Key inclusion criteria (1 listed)
- Korean capable of Multidetector-Row Cardiac Computed Tomography (MDCT)
Key exclusion criteria (3 listed)
- malignancy
- infection
- shock
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
Presence of coronary artery disease
Time frame: 5 years
1 secondary outcome
Mortality
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 25 Oct 2013.
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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.
Soo Lim, MD,PHD principal investigator
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 Cardiovascular Diseases and Cardiovascular Mortality, run by Seoul National University Bundang 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 1 inclusion and 3 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 25 Oct 2013. 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?
Presence of coronary artery disease (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 25 Oct 2013.