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

Acute Coronary Syndrome Clinical Trial

— CathEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317286
• Other study ID #: CathEF
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Left Ventricular Dysfunction
• Syndrome
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
Canada	Robert Avram	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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.