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
Verified date | September 2023 |
Source | CardioVascular Research Foundation, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CardioVascular Research Foundation, Korea |
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 |
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