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

NCT ID: NCT02847039

Last Updated: 2021-09-09

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Early Repolarization Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Early repolarization syndrome

Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified.

Blood samples

Intervention Type GENETIC

Blood samples at baseline.

Interventions

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Blood samples

Blood samples at baseline.

Intervention Type GENETIC

Eligibility Criteria

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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.

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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PROG/09/62

Identifier Type: -

Identifier Source: org_study_id

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