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NCT Number: NCT07220304

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Cardiovascular Inflammation Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corazon Imaging, Bay City, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
Ability to provide written informed consent
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.

Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA

Treatment and study plan

CaRi-Heart® Analysis

Device

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.

Other names: AI-based coronary inflammation analysis, CaRi-Heart Risk Score

Primary outcomes

Change in clinical management decisions following CaRi-Heart® analysis

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

HOUDA ABDALLAH, msn

CONTACT

[email protected]

3136587778

Sponsors and collaborators

Lead sponsor

Corazon Medical PC

Other

Registry information

Official study title

CaRi-Heart® Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA): A Prospective U.S. Community-Based Study on the Impact of CaRi-Heart® Analysis in Patients Undergoing CCTA for Coronary Artery Disease

Acronym: CARE-CCTA

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Oct 23, 2025
Registry last updated: Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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