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NCT Number: NCT05801432

A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Pil Hyung Lee, MD

SUB_INVESTIGATOR

Seung-Whan Lee, MD

CONTACT

Seung-Whan Lee, MD

PRINCIPAL_INVESTIGATOR

Tae Oh Kim, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The change in coronary atherosclerosis detected by initial and follow-up CCTA

    Time frame: about 10 years after first CCTA

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Sue HONG, RN

CONTACT

[email protected]

82 2-2045-3798

Seung-Whan Lee, MD

CONTACT

[email protected]

82 2-3010-3170

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Diabetes Follow-up Study for REduction of cardiovAscular outcoMes: a Coronary Computed Tomographic Angiography Cohort Study

Acronym: DREAM-CCTA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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