A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diabetes Follow-up Study for REduction of cardiovAscular outcoMes: a Coronary Computed Tomographic Angiography Cohort Study
Overview
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.
Primary outcome measures
- The change in coronary atherosclerosis detected by initial and follow-up CCTA [Time frame: about 10 years after first CCTA]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT05801432 · 2021-0759