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

Starting soon · Not applicable

Conditions studied: Coronary Artery Disease, Atherosclerosis, Cardiovascular Inflammation

In brief

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 facts

Study ID

NCT07220304

Run by

Corazon Medical PC

People needed

15000

Starts

2025-12-01

Expected to finish

2028-07-01

Last updated by the study team

2025-10-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Corazon Imaging — Bay City, Michigan, United States
• Corazon Imaging — Berkley, Michigan, United States
• Corazon Imaging — Caro, Michigan, United States
• Corazon Imaging — Dearborn, Michigan, United States
• Corazon Imaging — Flint, Michigan, United States
• Corazon Imaging — Grand Rapids, Michigan, United States
• Corazon Imaging — Livonia, Michigan, United States
• Corazon Imaging — Macomb, Michigan, United States
• Corazon Imaging — Madison Heights, Michigan, United States
• Corazon Imaging — Mount Pleasant, Michigan, United States
• Corazon Imaging — Novi, Michigan, United States
• Corazon Imaging — Saginaw, Michigan, United States
• Corazon Imaging — Saint Clair Shores, Michigan, United States
• Corazon Imaging — Sterling Heights, Michigan, United States
• Corazon Imaging — Trenton, Michigan, United States
• Corazon Imaging — Waterford, Michigan, United States
• Corazon Imaging — Elizabethtown, Pennsylvania, United States
• Corazon Imaging — Lemoyne, Pennsylvania, United States

Full record on ClinicalTrials.gov

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