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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02847039
Enrollment
200
Registered
2016-07-27
Start date
2008-01-01
Completion date
2021-12-31
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Repolarization Syndrome

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.

Interventions

GENETICBlood samples

Blood samples at baseline.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of ventricular fibrillation or sudden death36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026