Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter Registry
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT04279496
- Lead Sponsor
- Cleerly, Inc.
- Brief Summary
The overall objective of CONFIRM2 is to perform the largest cardiovascular phenotype outcomes study ever.
- Detailed Description
CONFIRM2 is a retrospective and prospective, open-label, international, multicenter observational registry designed to evaluate associations between CCTA imaging findings and clinical presentation (cross-sectional) and their ability to predict mortality and major adverse cardiac events (longitudinal) in patients with chronic CAD.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 35000
Inclusion Criteria
- Age >18 years
- Undergoing clinically indicated CCTA with >64-detector row CT
- Signed informed consent, including of release of medical information, long term follow-up and Health Insurance Portability and Accountability Act (HIPAA) documentation
Exclusion Criteria
- Individuals unable to provide informed consent
- Non-cardiac illness with life expectancy < 2 years
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coronary CT Angiography EvaluatioN For Clinical Outcomes June 2020- June 2022 Examined the totality of information visualized by coronary CT angiography (CCTA) for optimal refinement of prognostic risk stratification
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States