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.
Study Type
OBSERVATIONAL
Enrollment
300
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.
Time frame: Two weeks from initial review to review with CaRi-Heart results
To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).
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).
Time frame: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.
The percentage patients who have FAI-Score above the 75th percentile.
Time frame: Two weeks from initial review to review with CaRi-Heart results
Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).
The percentage patients with a CADRADs score of 0-1, who have FAI-Score above the 75th percentile.
Time frame: Two weeks from initial review to review with CaRi-Heart results
Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.
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.
Time frame: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).
The correlation coefficient for FAI-Score versus other available diagnostic test results (e.g., hsCRP, CACS etc.).
Time frame: Two weeks from initial review to review with CaRi-Heart results
Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)
The correlation coefficient for FAI-Score versus the quantitative plaque metrics.
Time frame: Two weeks from initial review to review with CaRi-Heart results
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.