NCT07220304Not yet recruiting
CaRi-Heart Assessment of Risk and Evaluation of Inflammation in Coronary CT Angiography (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
Source: ClinicalTrials.gov · Last updated 23 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15000 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Corazon Medical PC
- Diseases
- Coronary artery disease
- NCT number
- NCT07220304
What you commit to
- Study type: Interventional
- Planned participants: 15000
- From 1 Dec 2025 to the primary completion date, 31 Jan 2028
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- 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.
Other
- 4\. Inability to provide required health information 5. Pregnancy or any known contraindication for CCTA
Who the study is looking for
- Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
- Ability to provide written informed consent
- Patient between 18 and 80 years old
Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corazon Imaging Coordinator of this site? Confirm its status | Bay City | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Berkley | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Caro | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Dearborn | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Elizabethtown | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Lemoyne | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Livonia | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Macomb | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Madison Heights | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Mount Pleasant | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Novi | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Saginaw | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Saint Clair Shores | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Sterling Heights | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Trenton | United States | Unknown status |
| Corazon Imaging Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.