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

Completed

• Conditions: Acute Coronary Syndrome; Left Ventricular Dysfunction

• Registration Number: NCT05317286
• Lead Sponsor: Montreal Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-06-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Robert Avram; 🇨🇦 Montreal, Quebec, Canada