Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
Active, not recruiting
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT02803411
- Lead Sponsor
- Yonsei University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
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
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Exclusion Criteria
- poor image quality of CCTA
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in plaque volume and composition detected by follow up CCTA 2 years
- Secondary Outcome Measures
Name Time Method 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