Measurement of the Electromechanical Window to Improve the Diagnosis of Congenital Long QT Syndrome

NCT ID: NCT04328376

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2024-04-23

Brief Summary

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The goal of this research is to prospectively evaluate the performance of the electromechanical window according to a phonographic method, as a mean of diagnosis of long QT syndrome, and to compare its performance with routine tests used.

Detailed Description

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Familial long QT syndrome (LQTS) is a hereditary cardiac disorder in which most affected family members have delayed ventricular repolarization manifest on the electrocardiogram (ECG) as QT prolongation. This disease is associated with an increased propensity to palpitations, syncope, polymorphous ventricular tachycardia and sudden arrhythmic death. The diagnosis relies mostly on resting ECG findings and on genetic testing. In clinical practice however, this diagnosis is complicated by 2 main reasons: 1) a significant overlap in ECG findings between healthy and diseased individuals and 2) a frequent identification of genetic variants of unknown significance. Recent studies have suggested that echocardiographic measurement of the electromechanical window (EMW - the delay between the end of mechanical contraction and electrical activation of the heart) has better performance in the diagnosis of LQTS. The echocardiographic technique is however too complicated for routine clinical use. Preliminary work conducted at the University Hospital of Bordeaux and at the University Hospital of Reunion Island has demonstrated that a phonocardiographic approach leads to similar results with an improved feasibility and a good reproducibility.

Conditions

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Long QT Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Prospective FEMQT Group

Propositus patients with genetically proven LQTS and their relatives

Group Type EXPERIMENTAL

ECG coupled to phonocardiography

Intervention Type DIAGNOSTIC_TEST

A standard ECG is recorded along with a phonocardiographic recording. The phonocardiographic recording is obtained by using a specific electronic stethoscope plugged into the auxiliary port of the ECG machine. The recording takes less than 30 seconds. The two recording methods are concomitant.

QT interval is measured on the ECG recording, EMW is measured with ECG coupled to phonocardiography.

Interventions

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ECG coupled to phonocardiography

A standard ECG is recorded along with a phonocardiographic recording. The phonocardiographic recording is obtained by using a specific electronic stethoscope plugged into the auxiliary port of the ECG machine. The recording takes less than 30 seconds. The two recording methods are concomitant.

QT interval is measured on the ECG recording, EMW is measured with ECG coupled to phonocardiography.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Propositus patients with genetically proven LQTS and their relatives,
* Patients of both sexes aged 12 and over,
* Free, informed and written consent of the patient and the two holders of parental authority for minors.

Exclusion Criteria

* Inability to consent,
* Person deprived of liberty by judicial or administrative decision,
* Majors subject to a legal protection measure,
* Person participating in another research including an exclusion period still in progress,
* Severely impaired physical and / or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josselin DUCHATEAU, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Bordeaux University Hospital

Pessac, , France

Site Status

La Réunion University Hospital

Saint-Pierre, , France

Site Status

Toulouse University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2019/35

Identifier Type: -

Identifier Source: org_study_id

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