Clinical Trial

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)

Study acronym: SMART-CCTA-1
Not Yet Recruiting
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Record status
This record was last updated May 23, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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 be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.
Trial Details
NCT Number NCT06986733
Lead Sponsor Caristo Diagnostics Limited
Collaborators: Arkansas Cardiology, P.A., Baptist Health, Louisville, Northeast Georgia Hospital System
Conditions Cardiovascular Diseases
Enrollment 300 participants
Start Date 2025-06-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-23