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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically indicated CCTA undertaken for evaluation of coronary artery disease.
排除标准
- •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.
结局指标
主要结局
To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)