Clinical trial NCT06986733: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Caristo Diagnostics Limited
Sponsor class: INDUSTRY
Collaborators: name: Arkansas Cardiology, P.A.
name: Baptist Health, Louisville
name: Northeast Georgia Hospital System
First posted: 2025-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
timeFrame: Two weeks from initial review to review with CaRi-Heart results
Secondary outcomes:
measure: To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).
timeFrame: Two weeks from initial review to review with CaRi-Heart results
measure: Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.
timeFrame: Two weeks from initial review to review with CaRi-Heart results
measure: Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).
timeFrame: Two weeks from initial review to review with CaRi-Heart results
measure: Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.
timeFrame: Two weeks from initial review to review with CaRi-Heart results
measure: Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).
timeFrame: Two weeks from initial review to review with CaRi-Heart results
measure: Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)
timeFrame: Two weeks from initial review to review with CaRi-Heart results
Other outcomes:
measure: Prevalence of MACE in population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile)
timeFrame: Two weeks from initial review to review with CaRi-Heart results
Locations:
Study officials:
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