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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Left Ventricular Dysfunction

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Robert Avram

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults treated by percutaneous coronary intervention for ACS in whom left ventriculography is not contra-indicated and TTE-LVEF is expected to be measured in the next 24h to 7 days.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: CathEF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared to other researchers on reasonable request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No