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

Conditions

• Atherosclerosis
• Cardiovascular Inflammation
• Coronary Artery Disease

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Dec 31, 2025

Status verified

Oct 2025

Primary completion

Jan 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

15,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

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

Primary Outcome Measure

Change in clinical management decisions following CaRi-Heart® analysis [ Time Frame: Up to 60 days following CCTA completion ]

Central Contacts

• HOUDA ABDALLAH, msn
  3136587778
  [email protected]

Locations (18)

Find similar trials in Bay City, MI

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