Asan Medical Center CCTA Registry

• Sponsor: CardioVascular Research Foundation, Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT06036901
• Collaborator: (none)
• Enrollment: 6,343
• Actual Duration (Months): 192

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Risk Factor; Computed Tomography	Diagnostic Test: Coronary CT

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 6343 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Coronary Artery Disease in Asymptomatic Population Undergoing Coronary Computed Tomography Angiography: A Single Center, Prospective Observational Study
• Actual Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Dec 31, 2011
• Actual Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. The prevalence of CAD [5 years]

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

Secondary Outcome Measures

1. All cause mortality [5 years]

2. cardiovascular mortality [5 years]

   any death caused by a cardiovascular problem or if there was no identified cause of death

3. myocardial infarction [5 years]

   Number of participants with an increase in cardiac enzyme above the upper reference limit with ischemic symptoms or signs.

4. Revascularization [5 years]

   Number of participants with any percutaneous or surgical revascularization procedure during follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seung-Whan Lee, Principal investigator, clinical professor, CardioVascular Research Foundation, Korea
• ClinicalTrials.gov Identifier: NCT06036901
• Other Study ID Numbers: CardioVascularRF
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Sep 14, 2023