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| Name | Class |
|---|---|
| Arkansas Cardiology, P.A. | NETWORK |
| Baptist Health, Louisville | OTHER |
| Northeast Georgia Hospital System | UNKNOWN |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two weeks from initial review to review with CaRi-Heart results |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Two weeks from initial review to review with CaRi-Heart results |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of MACE in population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile) | A comparison of the number of major adverse cardiac events (MACE) in the population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile) | Two weeks from initial review to review with CaRi-Heart results |
Inclusion Criteria:
Exclusion Criteria:
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Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators
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| 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. | 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. | 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. | 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.). | 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. | Two weeks from initial review to review with CaRi-Heart results |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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