CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (CARE-CCTA)
CARE-CCTA
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
1 other identifier
interventional
15,000
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Dec 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2025
CompletedFirst Posted
Study publicly available on registry
October 23, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
October 23, 2025
October 1, 2025
2.1 years
October 22, 2025
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in clinical management decisions following CaRi-Heart® analysis
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
Up to 60 days following CCTA completion
Study Arms (1)
CaRi-Heart® Analysis Group
EXPERIMENTALParticipants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- Ability to provide written informed consent
- Patient between 18 and 80 years old
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Corazon Imaging
Bay City, Michigan, 48124, United States
Corazon Imaging
Berkley, Michigan, 48072, United States
Corazon Imaging
Caro, Michigan, 48723, United States
Corazon Imaging
Dearborn, Michigan, 48124, United States
Corazon Imaging
Flint, Michigan, 48532, United States
Corazon Imaging
Grand Rapids, Michigan, 49546, United States
Corazon Imaging
Livonia, Michigan, 48154, United States
Corazon Imaging
Macomb, Michigan, 48044, United States
Corazon Imaging
Madison Heights, Michigan, 48071, United States
Corazon Imaging
Mount Pleasant, Michigan, 48858, United States
Corazon Imaging
Novi, Michigan, 48377, United States
Corazon Imaging
Saginaw, Michigan, 48603, United States
Corazon Imaging
Saint Clair Shores, Michigan, 48080, United States
Corazon Imaging
Sterling Heights, Michigan, 48310, United States
Corazon Imaging
Trenton, Michigan, 48183, United States
Corazon Imaging
Waterford, Michigan, 48327, United States
Corazon Imaging
Elizabethtown, Pennsylvania, 17022, United States
Corazon Imaging
Lemoyne, Pennsylvania, 17043, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open-label study. Both investigators and participants are aware of CaRi-Heart® analysis results.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2025
First Posted
October 23, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
October 23, 2025
Record last verified: 2025-10