A Study to Evaluate Coronary Atherosclerosis in Patients With Diabetes Mellitus

NCT ID: NCT05801432

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

511 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-24

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seung-Whan Lee, M.D., Ph.D.

Part of cardiology, Principal Investigator, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ji Sue HONG, RN

Role: CONTACT

82 2-2045-3798

Seung-Whan Lee, MD

Role: CONTACT

82 2-3010-3170

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Seung-Whan Lee, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-0759

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The CRONOS-ADM Registry
NCT02070926 COMPLETED
Patients With Type 2 Diabetes
NCT07245082 RECRUITING