Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

• Conditions: Early Repolarization Syndrome
• Interventions: Genetic: Blood samples

• Registration Number: NCT02847039
• Lead Sponsor: Nantes University Hospital

Brief Summary

The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.

To try to answer these many questions, the approach will be twofold: clinical and genetic.

* Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.

* Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.

* 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.

A blood sample (15 ml) will be performed at inclusion.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
• Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
• Late potentials ventricular analyzable.
• For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
• For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.

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Exclusion Criteria

• Impossibility to receive clear information (patient's intellectual default).
• Refusal to sign the informed consent for participation.
• Under protective measure of justice.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early repolarization syndrome	Blood samples	Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified.

Primary Outcome Measures

Name	Time	Method
Incidence of ventricular fibrillation or sudden death	36 months

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France