IntErnationaL eLeCTRicAl storm registry (ELECTRA): Background, rationale, study design, and expected results

Continua l'arruolamento di pazienti per lo studio sulla grave emergenza aritmologica rappresentata dall'Electric Storm (Contemp Clin Trials Commun 2017 Jun 9)

4 May May 2018 4 months ago
  • Carbucicchio C, Catto V

Electrical storm (ES) is defined as three or more episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) within 24 h and is associated with an increased cardiac and all-cause mortality. It is a full arrhythmic emergency, and its prevalence steadily increasing along with the number of implantable cardioverter-defibrillator implanted every year in developed countries. Nowadays, little evidence exists regarding clinical predictors of ES and their potential association on mortality and heart failure (HF), nor optimal pharmacological and non-pharmacological treatment has ever been codified.

The intErnationaL eLeCTRicAl storm registry (ELECTRA) is a multicentre, observational, prospective clinical study. It aims to give a solid answer to many open questions. First, to estimate with good precision the incidence of death and cardiovascular events after ES over a long follow-up, describing mortality and re-hospitalization rates in patients. Second, to delineate which baseline characteristics are more commonly associated with ES, creating an international database on ES encompassing clinical features, pharmacological management, and interventional treatment strategies.

The primary endpoint is all-cause mortality 3 years after the ES index event. The main secondary endpoint is hospitalization for all causes 3 years after the ES index event. Other secondary endpoints includes ES recurrences, unclustered VTs/VFs recurrences, and hospitalizations for HF worsening.

Enrolment started on August 1st, 2016 and will continue until the summer of 2019. A minimum of 500 patients will be included in the registry, and all patients will be followed-up for a minimum of three years.

The present paper describes the background and current rationale of the ELECTRA study and details the study design, from enrolment strategy to data collection methods to planned data analysis. A brief overview of the expected results and their potential clinical and research implications will also be presented.

Reference
1. Guerra F, Accogli M, Bonelli P, Carbucicchio C, Catto V, Cipolletta L, De Ferrari GM, Dell'Era G, Dusi V, Fabregat-Andrés O, Flori M, Occhetta E, Palmisano P, Patani F, Proclemer A, Capucci A. IntErnationaL eLeCTRicAl storm registry (ELECTRA): Background, rationale, study design, and expected results. Contemp Clin Trials Commun 2017 Jun 9;7:69-72. Go to full text