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

NCT02847039 | Unknown

• 1 other identifier: PROG/09/62
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Repolarization Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of ventricular fibrillation or sudden death

  36 months

Study Arms (1)

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.

Genetic: Blood samples

Interventions

Blood samples GENETIC

Blood samples at baseline.

Early repolarization syndrome

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 27, 2016
• Study Start: January 1, 2008
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

FR (1)