Coronary DiseaseNCT01170403
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans
An observational study of Coronary Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
64 channel 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 type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- How many people
- 15,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Jun 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who had undertook a computed tomographic angiography (CTA) with 64-slice MDCT from January 2nd 2006 until August 21st 2008. Reasons for exam include screening in asymptomatic subjects, diagnosis in patients with angina pectoris, follow up after percutaneous coronary intervention or coronary artery bypass grafting, differential diagnosis in chest pain and so on.
Who may be able to join
- Patients aged 18 years or older
Who cannot join
- pregnant women
- patients with chronic kidney disease (Cr>2.0)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, 463-707
About this study
Official title: Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data of Over 15,000 Individuals in Korea
64 channel 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 type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. The investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.
- Conditions
- Coronary Disease
- Keywords
- coronary heart disease, Multidetector row cardiac computed tomography, type 2 diabetes, metabolic syndrome
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2, Metabolic Syndrome
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 |
|---|---|---|
| NGT/IFG/DM, MeS/no-MeS | NGT: normal glucose tolerance IFG: impaired glucose tolerance DM : diabetes mellitus MeS: metabolic syndrome no-MeS: no metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJan 2006
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Lipidology and Atherosclerosis
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170403
- Sponsor's protocol ID
- M10642140004-06N4214-00410
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2010
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data of Over 15,000 Individuals in Korea
- ClinicalTrials.gov ID
- NCT01170403
- Acronym / sponsor ID
- M10642140004-06N4214-00410
- Conditions
- Coronary Disease
- Keywords
- coronary heart disease, Multidetector row cardiac computed tomography, type 2 diabetes, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- The Korean Society of Lipidology and Atherosclerosis
- Study start
- Jan 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 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.
64 channel 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 type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. The investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGT/IFG/DM, MeS/no-MeS | – | –NGT: normal glucose tolerance IFG: impaired glucose tolerance DM : diabetes mellitus MeS: metabolic syndrome no-MeS: no metabolic syndrome |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who had undertook a computed tomographic angiography (CTA) with 64-slice MDCT from January 2nd 2006 until August 21st 2008. Reasons for exam include screening in asymptomatic subjects, diagnosis in patients with angina pectoris, follow up after percutaneous coronary intervention or coronary artery bypass grafting, differential diagnosis in chest pain and so on.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older
Key exclusion criteria (2 listed)
- pregnant women
- patients with chronic kidney disease (Cr>2.0)
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
Cardiovascular event
Time frame: five 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 9 Jul 2014.
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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.
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 Disease, 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 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: finished, as of the sponsor's last update on 9 Jul 2014. 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?
Cardiovascular event (time frame: five 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 9 Jul 2014.