Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05829993

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-31

5000

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

UMMISCO - Institute of Research for Development (IRD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Torsades de Pointes (TdP) are potentially fatal ventricular arrhythmias that are promoted by prolonged ventricular repolarization (Long QT, LQT). The different forms of LQT result from inhibition of cardiac potassium currents (IKr and IKs) or activation of a late sodium current (INaL). These alterations may be either congenital (3 types: cLQT-1: IKs, cLQT-2: IKr, cLQT-3: INaL) or drug-induced (diLQT, via inhibition of IKr). More than 100 medications have received marketing authorization despite a known risk of TdP, due to a favorable benefit-risk ratio (e.g., hydroxychloroquine). QTc, which represents the duration of ventricular repolarization (in milliseconds) - defined as the time from the beginning of the QRS complex to the end of the T wave, corrected for heart rate - is prolonged in all forms of LQT. Specific T-wave abnormalities, depending on the altered ion currents, have been described and can help differentiate the various types of congenital or drug-induced LQT. However, screening for LQT and TdP risk, both at the individual and population levels, currently relies mainly on isolated QTc evaluation and genetic testing, which often takes considerable time to return. Thus, limiting ECG analysis to QTc measurement alone offers low predictive value, as the ECG contains a wealth of additional information beyond a single interval. The investigator recently demonstrated that artificial intelligence (AI)-based ECG analysis using deep-learning convolutional neural networks can detect more discriminative features of the ECG for predicting the type of LQT and the risk of TdP, going beyond QTc alone. Using these techniques, the investigator developed a model with probabilistic modules capable of: predicting TdP risk, identifying LQT subtypes (scores ranging from 0 to 100%), and quantitatively measuring ECG parameters such as QTc, heart rate, PR, and QRS duration. The objective of this project is to prospectively validate our model in real-world conditions across various departments within AP-HP, for: Automatic measurement of QTc, and Identification and classification of LQT types and TdP risk.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients or subjects receiving care at recruiting centers who require an ECG
  • No objection to participating in the study
Not Eligible

You will not qualify if you...

  • Medical reasons preventing ECG
  • Presence of a pacemaker-driven QRS

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre d'Investigation Clinique Paris-Est/Hôpital Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

J

Joe-Elie SALEM, PU-PH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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