LVEF Prediction During ACS Using AI Algorithm Applied on Coronary Angiogram Videos

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Acute Coronary Syndrome, Left Ventricular Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed by the participant Acute coronary syndrome Creatinine clearance ≥30 ml/min/m2 according to MDRD Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve-Receiver Operating Characteristics (AUC-ROC) of the CathEF algorithm for differentiating a LVEF ≤ or >50%, compared to TTE-LVEF |  | Either 7 days before or up to 7 days after the coronary angiogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence