- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170403
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans
July 7, 2014 updated by: Soo Lim, Seoul National University Bundang Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
15000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bundang-gu
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Seongnam, Bundang-gu, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Patients aged 18 years or older
Exclusion Criteria:
- pregnant women
- patients with chronic kidney disease (Cr>2.0)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiovascular event
Time Frame: five years
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 22, 2010
First Submitted That Met QC Criteria
July 26, 2010
First Posted (Estimate)
July 27, 2010
Study Record Updates
Last Update Posted (Estimate)
July 9, 2014
Last Update Submitted That Met QC Criteria
July 7, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10642140004-06N4214-00410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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