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

NCT04328376 | Completed

• 1 other identifier: CHUBX 2019/35
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Long QT Syndrome

Keywords

Long QT syndrome; Electromechanical window; Phonocardiography

Outcome Measures

Primary Outcomes (1)

• Negative predictive value (NPV) obtained by the two methods of diagnosis

  The NPV is measured in percentage. The NPV of LQTS diagnosis obtained by phonocardiographic method (measurement of the EMW) and the NPV obtained by standard ECG method (QT measurement prolongation) will be compared.

  Day 1

Secondary Outcomes (4)

• Values of sensitivity obtained by the two methods of diagnosis

  Day 1

• Values of specificity obtained by the two methods of diagnosis

  Day 1

• Positive predictive values obtained by the two methods of diagnosis

  Day 1

• Area Under the Curves (AUC) obtained by the two methods of diagnosis

  Day 1

Study Arms (1)

Prospective FEMQT Group

EXPERIMENTAL

Propositus patients with genetically proven LQTS and their relatives

Diagnostic Test: ECG coupled to phonocardiography

Interventions

ECG coupled to phonocardiography 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.

Prospective FEMQT Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to consent,
• Person deprived of liberty by judicial or administrative decision,
• Majors subject to a legal protection measure,
• Severely impaired physical and / or psychological health, which, according to the investigator, may affect the participant's compliance with the study.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

Nantes University Hospital

Nantes, 44093, France

Location

Bordeaux University Hospital

Pessac, 33604, France

Location

La Réunion University Hospital

Saint-Pierre, 97410, France

Location

Toulouse University Hospital

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josselin DUCHATEAU, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: August 28, 2020
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

FR (4)