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 Coronary CT Angiography (CCTA) exam. The goal is to determine whether the additional information provided by CaRi-Heart® changes clinical decision-making and helps improve early identification and management of coronary artery disease in community imaging centers. Patients who undergo CCTA as part of their regular care will be invited to have their scans analyzed using CaRi-Heart® at no extra cost, time, or radiation.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15,000
CaRi-Heart® is an artificial-intelligence-based software device that analyzes coronary CT angiography (CCTA) images to quantify coronary inflammation and generate a CaRi-Heart Risk Score. The analysis provides color-coded visualization and quantitative metrics derived from perivascular fat tissue characteristics, enabling improved assessment of coronary artery disease risk. In this study, CaRi-Heart® analysis is applied prospectively to CCTA images obtained as part of standard clinical care. The results are reviewed by the interpreting physician and recorded to determine whether the additional information affects diagnostic interpretation or management decisions. No additional imaging, radiation, or contrast exposure occurs.
Corazon Imaging
Bay City, Michigan, United States
Corazon Imaging
Berkley, Michigan, United States
Corazon Imaging
Caro, Michigan, United States
Corazon Imaging
Dearborn, Michigan, United States
Corazon Imaging
Flint, Michigan, United States
Corazon Imaging
Grand Rapids, Michigan, United States
Corazon Imaging
Livonia, Michigan, United States
Corazon Imaging
Macomb, Michigan, United States
Corazon Imaging
Madison Heights, Michigan, United States
Corazon Imaging
Mount Pleasant, Michigan, United States
...and 8 more locations
Change in clinical management decisions following CaRi-Heart® analysis
The proportion of patients for whom the addition of CaRi-Heart® analysis to standard Coronary CT Angiography (CCTA) results in a change in clinical management decisions, such as initiation or adjustment of preventive therapies (e.g., statins, antiplatelet agents, lifestyle modification, or cardiology referral). Management decisions before and after reviewing CaRi-Heart® results will be compared to quantify impact on diagnostic interpretation and treatment planning
Time frame: Up to 60 days following CCTA completion
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