Prospective Validation of a Deep Learning Algorithm for Prediction of the Left Ventricular Ejection Fraction From Coronary Angiogram Videos in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF
研究概览
简要总结
Left ventricular ejection fraction (LVEF) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (ACS). Transthoracic echocardiography (TTE) remains the gold standard for LVEF measurement. Currently, LVEF can be estimated at the time of the coronary angiogram but requires a ventriculography. This latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. Artificial intelligence (AI) has previously been shown to be an accurate method for determining LVEF using different data sources. Fur the purpose of this study, we aim at validating prospectively an AI algorithm, called CathEF, for the prediction of real-time LVEF (AI-LVEF) compared to TTE-LVEF and ventriculography in patients undergoing coronary angiogram for ACS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the participant
- •Acute coronary syndrome
- •Creatinine clearance ≥30 ml/min/m2 according to MDRD
排除标准
- •Creatinine clearance <30 ml/min/m2 according to MDRD
- •No indication to perform TTE in the 7 days following coronary angiogram
- •Right bundle branch block
- •Suspected or confirmed left ventricular thrombus
- •Suspected or confirmed aortic dissection
- •Ventriculography not feasible
- •No left coronary system angiogram
结局指标
主要结局
Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF
时间窗: Either 7 days before or up to 7 days after the coronary angiogram
次要结局
- Sensitivity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.(Either 7 days before or up to 7 days after the coronary angiogram)
- Sensitivity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%(Either 7 days before or up to 7 days after the coronary angiogram)
- Likert scale on the impact on the procedure, ease of use and utility of the CathEF algorithm in the clinical practice, as assessed by interventional cardiologists(Through study completion, an average of 1 year.)
- Comparing AUC-ROC of CathEF and ventriculography for differentiating a LVEF ≤ or >50%(Either 7 days before or up to 7 days after the coronary angiogram)
- AUC-ROC of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%(Either 7 days before or up to 7 days after the coronary angiogram)
- Specificity of CathEF and ventriculography for differentiating a LVEF ≤ or >50% in comparison to TTE-LVEF.(Either 7 days before or up to 7 days after the coronary angiogram)
- Specificity of the re-trained CathEF algorthim for differentiating a LEVF ≤ or >50%(Either 7 days before or up to 7 days after the coronary angiogram)
- Number of participants with major adverse cardiovascular events (Combined outcome of combined outcomeof mortality, ventricular arrhythmia requiring an intervention, heart failure, need for inotropic support, renal failure KDIGO≥2 and stroke)(At 7 days or before discharge, if earlier.)
研究者
Robert Avram
Principal Investigator
Montreal Heart Institute