Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias — DEEPECG4U  

Cardiac Disease Clinical Trial

Official title: Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

Status Recruiting

Clinical Trial Summary

The objective of this study is to prospectively validate in real life cohorts from various departments of the APHP our artificial intelligence (deep-learning) models allowing for :

1. automatic measurement of various ECG quantitative features,

2. identification and typing of LQT and risk of TdP.

Clinical Trial Description

Torsade-de-Pointes (TdP) are potentially fatal ventricular arrhythmias favored by a prolongation of ventricular repolarization (Long QT, LQT). The different types of existing LQT derive from the inhibition of cardiac potassium currents (IKr ; IKs) or the activation of a late sodium current (INaL). These alterations can be of congenital origin (3 types=>cLQT-1:IKs, cLQT-2:IKr, cLQT-3: INaL) or drug-induced (diLQT, via inhibition of IKr). More than 100 drugs have marketing authorization despite a risk of TdP because they have a favorable benefit/risk ratio (e.g. hydroxychloroquine).

QTc, which represents the duration of ventricular repolarization (msec) and corresponds to the time between the beginning of the QRS and the end of the T-wave, corrected by heart rate, is prolonged in all LQT. Specific T-wave abnormalities as a function of the altered currents have been described and helps to discriminate cLQT/diLQT types. Thus, limiting the analysis of the ECG to that of the QTc is not very predictive because the information contained in an ECG is much richer and is not limited to the simple measurement of an interval.

We have recently shown that analysis of ECGs using artificial intelligence (convolutional neural network, deep-learning) identifies elements of the ECG that are more discriminating in the prediction of the type of LQT and the risk of TdP, beyond of QTc. With these techniques, we have developed a model with probabilistic modules that predict the risk of TdP, identify the type of LQT (score ranging from 0 to 100%) and allow for the quantitative measurements of various common ECG parameters (including QTc, heart rate, PR and QRS).

The objective of the project is to prospectively validate in real life cohorts from various departments of the APHP our model allowing for :

1. automatic QTc measurement,

2. identification and typing of LQT and risk of TdP. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Disease
• Heart Diseases
• Ventricular Arrythmia

• NCT number: NCT05829993
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Joe-Elie SALEM, PU-PH
• Phone: 0033 1 42 17 85 35
• Email: joe-elie.salem@aphp.fr
• Status: Recruiting
• Start date: November 28, 2023
• Completion date: June 2024