NCT06036901

Brief Summary

A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. All participants were provided with information about the potential benefits and risks of CCTA and made the decision to undergo the procedure at their own expense. They were also informed that their clinical and radiological data would be used for this study and gave their consent. Of these individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2011

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

August 15, 2023

Last Update Submit

September 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The prevalence of CAD

    Diameter stenosis \>50% in any coronary artery by coronary CT angiography

    5 years

Secondary Outcomes (4)

  • All cause mortality

    5 years

  • cardiovascular mortality

    5 years

  • myocardial infarction

    5 years

  • Revascularization

    5 years

Interventions

Coronary CTDIAGNOSTIC_TEST

Coronary CT evaluation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 20 years and older had undergone self-referral CCTA evaluation as part of a general health examination in the Health Screening and Promotion Center at Asan Medical Center from January 2007 to December 2011.

You may not qualify if:

  • a previous history of angina or myocardial infarction;
  • abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST segments or T wave changes, or left bundle-branch blocks;
  • insufficient medical records;
  • structural heart diseases;
  • a prior history of open heart surgery or percutaneous coronary intervention;
  • a previous cardiac procedure; or
  • renal insufficiency (creatinine N1.5 mg/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, clinical professor

Study Record Dates

First Submitted

August 15, 2023

First Posted

September 14, 2023

Study Start

January 1, 2007

Primary Completion

December 31, 2011

Study Completion

December 31, 2022

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share