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

Early Repolarization Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02847039
• Other study ID #: PROG/09/62
• Status: Active, not recruiting
• Start date: January 1, 2008
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Repolarization Syndrome
• Syndrome

Intervention

Genetic:
• Blood samples
Blood samples at baseline.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ventricular fibrillation or sudden death		36 months