A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus
ConditionDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
About 511 consecutive 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, will be screened for enrollment in this study. A member of research team should review the patients' medical history for eligibility. If all eligibility criteria are met and written informed consent is provided, the patient may be enrolled in the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The change in coronary atherosclerosis detected by initial and follow-up CCTA
the natural history of coronary atherosclerotic plaque development and progression over time by CCTA
Time frame
about 10 years after first CCTASponsors and contacts
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Source ClinicalTrials.gov