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A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

Recruiting
Conditions
Diabetes Mellitus
Registration Number
NCT05801432
Lead Sponsor
Asan Medical Center
Brief Summary

The purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by CCTA and to identify risk factors attributable to the development of coronary atherosclerosis in a Korean DM population.

Detailed Description

Patients with diabetes mellitus, who underwent initial CCTA (coronary computed tomographic angiography) at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be evaluated for inclusion in the study. All DREAM-CCTA study patients will undergo follow-up CCTA based on order from their primary physician. CCTA and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial CCTA and at the time of follow-up CCTA.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
511
Inclusion Criteria
  • Age 19 years or older
  • Asymptomatic patients with type 2 DM who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012
  • Willing and able to provide informed written consent
Exclusion Criteria
  • Blood test results that the Creatinine level exceeds 1.5 mg/dL
  • A person with a history of anaphylaxis or allergic shock associated with a contrast medium
  • Pregnant women
  • Unable to undergo follow-up CCTA
  • Uninterpretable CCTA

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The change in coronary atherosclerosis detected by initial and follow-up CCTAabout 10 years after first CCTA

the natural history of coronary atherosclerotic plaque development and progression over time by CCTA

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

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