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Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans

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ClinicalTrials.gov Identifier: NCT01170403
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 9, 2014
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease
Coronary Disease

Study Design

Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data of Over 15,000 Individuals in Korea
Study Start Date : January 2006
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

NGT: normal glucose tolerance IFG: impaired glucose tolerance DM : diabetes mellitus MeS: metabolic syndrome no-MeS: no metabolic syndrome

Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular event [ Time Frame: five years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • Patients aged 18 years or older

Exclusion Criteria:

  • pregnant women
  • patients with chronic kidney disease (Cr>2.0)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170403

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
The Korean Society of Lipidology and Atherosclerosis
More Information

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01170403     History of Changes
Other Study ID Numbers: M10642140004-06N4214-00410
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
coronary heart disease
Multidetector row cardiac computed tomography
type 2 diabetes
metabolic syndrome

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases