Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Yonsei University
- Enrollment
- 2000
- Primary Endpoint
- Change in plaque volume and composition detected by follow up CCTA
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.
Detailed Description
All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.
Investigators
Hyuk-Jae Chang
Professor
Yonsei University
Eligibility Criteria
Inclusion Criteria
- •patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation
- •patients underwent at least 2 year interval between the baseline and follow-up CCTA
Exclusion Criteria
- •poor image quality of CCTA
Outcomes
Primary Outcomes
Change in plaque volume and composition detected by follow up CCTA
Time Frame: 2 years
Secondary Outcomes
- Myocardial infarction (yes or no)(2 years)
- Revascularization (yes or no)(2 years)
- Cardiac mortality (yes or no)(2 years)
- Unstable angina requiring hospitalization (yes or no)(2 years)