Status:
NOT_YET_RECRUITING
CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)
Lead Sponsor:
Corazon Medical PC
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study evaluates the use of CaRi-Heart® analysis, an artificial-intelligence (AI) software tool that measures inflammation in the coronary arteries using images already captured during a standard ...
Detailed Description
This is a prospective, community-based interventional study designed to assess the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for evaluation of sus...
Eligibility Criteria
Inclusion
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- Ability to provide written informed consent
- Patient between 18 and 80 years old
Exclusion
- \- 1. History of surgical revascularization (coronary artery bypass graft, CABG) 2. CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR) 3. The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
- 4\. Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT07220304
Start Date
December 1 2025
End Date
July 1 2028
Last Update
October 23 2025
Active Locations (18)
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1
Corazon Imaging
Bay City, Michigan, United States, 48124
2
Corazon Imaging
Berkley, Michigan, United States, 48072
3
Corazon Imaging
Caro, Michigan, United States, 48723
4
Corazon Imaging
Dearborn, Michigan, United States, 48124