Asan Medical Center CCTA Registry

Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Computed Tomography; Risk Factor
• Intervention / Treatment: Diagnostic test: Coronary CT

• Study Type: Observational
• Enrollment (Actual): 6343

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of CAD	Diameter stenosis >50% in any coronary artery by coronary CT angiography	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		5 years
cardiovascular mortality	any death caused by a cardiovascular problem or if there was no identified cause of death	5 years
myocardial infarction	Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.	5 years
Revascularization	Number of participants with any percutaneous or surgical revascularization procedure during follow-up.	5 years

Collaborators and Investigators

• Sponsor: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2011
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CardioVascularRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No