Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)

Not yet recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT06986733
• Lead Sponsor: Caristo Diagnostics Limited

Brief Summary

This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinically indicated CCTA undertaken for evaluation of coronary artery disease.

Exclusion Criteria

• History of surgical revascularization (coronary artery bypass graft, CABG)
• CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
• The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.	Two weeks from initial review to review with CaRi-Heart results	The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.

Secondary Outcome Measures

Name	Time	Method
To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).	Two weeks from initial review to review with CaRi-Heart results	The percentage of patients reclassified into a higher (or lower) risk category using the CaRi-Heart® based AI-Risk classification, when compared to standard clinical risk assessment tools (i.e., ASCVD-PCE).
Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.	Two weeks from initial review to review with CaRi-Heart results	The percentage patients who have FAI-Score above the 75th percentile.
Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).	Two weeks from initial review to review with CaRi-Heart results	The percentage patients with a CADRADs score of 0-1, who have FAI-Score above the 75th percentile.
Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.	Two weeks from initial review to review with CaRi-Heart results	The percentage patients who have FAI-Score above the 75th percentile in each of the following sub-groups: geographical location, patient age, patient sex, patient ancestry.
Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).	Two weeks from initial review to review with CaRi-Heart results	The correlation coefficient for FAI-Score versus other available diagnostic test results (e.g., hsCRP, CACS etc.).
Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)	Two weeks from initial review to review with CaRi-Heart results	The correlation coefficient for FAI-Score versus the quantitative plaque metrics.