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CaRi-Heart Assessment of Risk...

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

NCT ID: NCT07220304

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Artery Disease Atherosclerosis Cardiovascular Inflammation

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Open-label study. Both investigators and participants are aware of CaRi-Heart® analysis results.

Study Groups

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CaRi-Heart® Analysis Group

Participants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making.

Group Type EXPERIMENTAL

CaRi-Heart® Analysis

Intervention Type 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.

Interventions

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CaRi-Heart® Analysis

Intervention Type DEVICE

Other Intervention Names

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AI-based coronary inflammation analysis CaRi-Heart Risk Score

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers