CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)

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 suspected or known coronary artery disease. CaRi-Heart® is a software-as-a-medical-device (SaMD) that uses advanced AI algorithms to quantify coronary inflammation and generate a CaRi-Heart® Risk Score from existing CCTA images. The analysis provides color-coded visualization and quantitative metrics that may improve risk stratification beyond traditional plaque and stenosis assessment. The study aims to compare management decisions made before and after review of the CaRi-Heart® analysis, measuring how often the additional information influences diagnostic interpretation or changes treatment recommendations (such as preventive therapy or referral). Approximately 15,000 participants will be enrolled across multiple outpatient imaging centers in Michigan. All data will be collected under standard clinical workflows with IRB approval, informed consent, and HIPAA compliance. No additional scanning, contrast, or radiation exposure will occur.