CaRi-Heart® Analysis for Coronary Artery Disease

This study is evaluating a new artificial intelligence (AI) software called CaRi-Heart® Analysis. This software looks at images from your regular Coronary CT Angiography (CCTA) scan to measure inflammation in your heart arteries. The goal is to see if this extra information helps doctors make better decisions about your care for coronary artery disease (a condition where plaque builds up in the heart's arteries). You can join if you are between 18 and 80 years old, are having a CCTA for suspected or known coronary artery disease, and have not had bypass surgery. The study will be successful if doctors change their treatment plans more often after seeing the CaRi-Heart® results, helping to identify and manage heart disease earlier. This study is currently recruiting about 15,000 participants.

Study design
This is an interventional study involving about 15,000 participants. It aims to compare doctors' decisions before and after using the CaRi-Heart® Analysis.
What's involved
You would undergo a standard CCTA scan as part of your regular care. Your existing CCTA images would then be analyzed by the CaRi-Heart® software; no additional scans or procedures are needed from you.
Compensation
Not stated in the trial record.
Follow-up
Your clinical management decisions will be assessed for up to 60 days following your CCTA completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220304

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

Not Yet Recruiting
NAAll AgesInterventionalDiagnostic
Corazon Medical PC
~15,000 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:CaRi-Heart® Analysis

At a glance

Recruiting sites
0 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in clinical management decisions following CaRi-Heart® analysis
Measured over Up to 60 days following CCTA completion
Coronary Artery Disease
Atherosclerosis
Cardiovascular Inflammation
18 sites across 2 states
Michigan16
Pennsylvania2

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  • Change in clinical management decisions following CaRi-Heart® analysisUp to 60 days following CCTA completion

    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