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NCT05801432 Clinical Trial

A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— DREAM-CCTA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05801432
Other study ID # 2021-0759
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2021
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source Asan Medical Center
Contact Ji Sue HONG, RN
Phone 82 2-2045-3798
Email sue5165@naver.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 511
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 about 10 years after first CCTA
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