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

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ClinicalTrials.gov Identifier: NCT04328376
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Diagnostic Test: ECG coupled to phonocardiography Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurement of the Electromechanical Window to Improve the Diagnosis of Congenital Long QT Syndrome
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : August 28, 2023
Estimated Study Completion Date : August 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prospective FEMQT Group
Propositus patients with genetically proven LQTS and their relatives
 Diagnostic Test: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Negative predictive value (NPV) obtained by the two methods of diagnosis [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Values of sensitivity obtained by the two methods of diagnosis [ Time Frame: Day 1 ]
    Value of sensitivity is measured in percentage. The values of sensitivity of EMW and standard ECG will be compared.

  2. Values of specificity obtained by the two methods of diagnosis [ Time Frame: Day 1 ]
    Value of specificity is measured in percentage. The values of specificity of EMW and standard ECG will be compared.

  3. Positive predictive values obtained by the two methods of diagnosis [ Time Frame: Day 1 ]
    Positive predictive value is measured in percentage. Positive predictive values of EMW and standard ECG will be compared.

  4. Area Under the Curves (AUC) obtained by the two methods of diagnosis [ Time Frame: Day 1 ]

    The AUC obtained by Receiver Operating Characteristic (ROC) analyses is measured by a value between 0 and 1.

    The AUC obtained by ROC of EMW and standard ECG will be compared.



Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328376


Contacts
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Contact: Josselin DUCHATEAU, MD (0)5 57 65 64 01 ext +33 josselin.duchateau@chu-bordeaux.fr
Contact: Carine LOPEZ (0)5 24 54 91 17 ext +33 carine.lopez@chu-bordeaux.fr

Locations
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France
Nantes University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Vincent PROBST, MD PhD    (0)2 40 16 52 79 ext +33    vincent.probst@chu-nantes.fr   
Principal Investigator: Vincent PROBST, MD PhD         
Bordeaux University Hospital Recruiting
Pessac, France, 33604
Contact: Josselin DUCHATEAU, MD    (0)5 57 65 64 01 ext +33    josselin.duchateau@chu-bordeaux.fr   
Contact: Carine LOPEZ    (0)5 24 54 91 17 ext +33    carine.lopez@chu-bordeaux.fr   
Principal Investigator: Josselin DUCHATEAU, MD         
Sub-Investigator: Frédéric SACHER, MD, PhD         
Sub-Investigator: Romain TIXIER, MD         
La Réunion University Hospital Recruiting
Saint-Pierre, France, 97410
Contact: Maxime CHURET, MD    02 62 35 91 53 ext +33    maxime.churet@chu-reunion.fr   
Principal Investigator: Maxime CHURET, MD         
Sub-Investigator: Olivier GEOFFROY, MD         
Toulouse University Hospital Recruiting
Toulouse, France, 31400
Contact: Jean-Philippe MAURY, MD PhD    (0)5 61 32 34 70 ext +33    maury.p@chu-toulouse.fr   
Principal Investigator: jean-Philippe MAURY, MD PhD         
Sub-Investigator: Anne ROLLIN, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Josselin DUCHATEAU, MD University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04328376    
Other Study ID Numbers: CHUBX 2019/35
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Long QT syndrome
Electromechanical window
Phonocardiography
Additional relevant MeSH terms:
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Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities