Atherosclerosis, Cardiovascular Inflammation, Coronary Artery Disease
Conditions
Keywords
CaRi-Heart, Coronary CT Angiography (CCTA), AI Cardiac Imaging, Coronary Inflammation, Cardiovascular Risk Stratification, Plaque Characterization, Community-Based Imaging, Noninvasive Cardiac Diagnostics, Artificial Intelligence in Cardiology
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 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.
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 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.
Interventions
DEVICECaRi-Heart® Analysis
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.
Sponsors
Corazon Medical PC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Open-label study. Both investigators and participants are aware of CaRi-Heart® analysis results.
Intervention model description
Single-arm prospective diagnostic study evaluating the incremental value of CaRi-Heart® analysis in patients undergoing Coronary CT Angiography (CCTA) for suspected or known coronary artery disease
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Clinically indicated CCTA undertaken for evaluation of coronary artery disease. 2. Ability to provide written informed consent 3. Patient between 18 and 80 years old
Exclusion criteria
\- 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical management decisions following CaRi-Heart® analysis | Up to 60 days following CCTA completion | 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 |
Countries
United States
Contacts
Primary ContactHOUDA ABDALLAH, msn
Outcome results
None listed