NCT05801432

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Aug 2021Dec 2026

Study Start

First participant enrolled

August 24, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5.4 years

First QC Date

March 22, 2023

Last Update Submit

March 26, 2026

Conditions

Diabetes Mellitus

Outcome Measures

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

    about 10 years after first CCTA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Ji Sue HONG, RN

CONTACT

82 2-2045-3798sue5165@naver.com

Seung-Whan Lee, MD

CONTACT

82 2-3010-3170seungwlee@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Part of cardiology, Principal Investigator, associate professor

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 6, 2023

Study Start

August 24, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)