Status:
NOT_YET_RECRUITING
Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)
Lead Sponsor:
Caristo Diagnostics Limited
Collaborating Sponsors:
Arkansas Cardiology, P.A.
Baptist Health, Louisville
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
30-80 years
Brief Summary
This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will...
Eligibility Criteria
Inclusion
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
Exclusion
- History of surgical revascularization (coronary artery bypass graft, CABG)
- CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
- The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06986733
Start Date
June 1 2025
End Date
December 31 2025
Last Update
May 23 2025
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