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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170403
Other study ID # M10642140004-06N4214-00410
Secondary ID
Status Completed
Phase N/A
First received July 22, 2010
Last updated July 7, 2014
Start date January 2006
Est. completion date June 2014

Study information

Verified date July 2014
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 15000
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients aged 18 years or older

Exclusion Criteria:

- pregnant women

- patients with chronic kidney disease (Cr>2.0)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Bundang-gu

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital The Korean Society of Lipidology and Atherosclerosis

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular event five years No
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