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ClinicalTrials.gov ID

NCT07220304

Lead Sponsor

Corazon Medical PCOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

15,000Estimated

Last Update Posted

Oct 23, 2025Actual

Start Date

Dec 2025Estimated

Primary Completion Date

Jan 2028Estimated

Completion Date

Jul 2028Estimated

Official 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

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.

• Coronary Artery Disease
• Atherosclerosis
• Cardiovascular Inflammation

• CaRi-Heart® Analysis

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Corazon Medical PCOTHER

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778

habdallah@corazonimaging.com3136587778