Asan Medical Center CCTA Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036901
• Other study ID #: CardioVascularRF
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6343
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Computed Tomography
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Risk Factor

Intervention

Diagnostic Test:
• Coronary CT
Coronary CT evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CardioVascular Research Foundation, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of CAD	Diameter stenosis >50% in any coronary artery by coronary CT angiography	5 years
Secondary	All cause mortality		5 years
Secondary	cardiovascular mortality	any death caused by a cardiovascular problem or if there was no identified cause of death	5 years
Secondary	myocardial infarction	Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.	5 years
Secondary	Revascularization	Number of participants with any percutaneous or surgical revascularization procedure during follow-up.	5 years