Diabetes Mellitus Clinical Trial
Official title:
DEtection of Subclinical Coronary AtheRosclerosis in diabeTES Using Coronary CT Angiography (DESCARTES Trial)
The purpose of this study is to evaluate the prevalence and clinical predictors of subclinical coronary atherosclerosis and to validate the usefulness of coronary CT angiography as a screening tool in asymptomatic patients with type 2 diabetes mellitus.
Status | Completed |
Enrollment | 1000 |
Est. completion date | December 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 2 diabetes mellitus - Age 50 ~ 75 years Exclusion Criteria: - angina pectoris or anginal equivalent symptoms - insulin pump user or history of ketoacidosis - history of myocardial infarction, heart failure, or coronary revascularization - electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block - uncontrolled arrythmia - hypersensitivity to contrast dye - renal failure - uncontrolled arrythmia - hypersensitivity to contrast dye - renal failure |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang hospital | Sungnam-si | Kyungki-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial infarction | |||
Primary | Late revascularization therapy | |||
Primary | Cardiac death | |||
Secondary | Early revascularization therapy | |||
Secondary | Other procedure (i.e. peripheral vascular procedure) | |||
Secondary | All-caused death |
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