International Electrical Storm Registry

NCT02882139 | Unknown

• 1 other identifier: 2016-0364 OR
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP) and ventricular fibrillation (VF)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (SCD). Recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called "electrical storm" (ES) has emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments. Most of the patients presenting ES are already implanted with an ICD. This is due to 3 factors: first, patients with ICD implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. Third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an ES. The incidence of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for secondary prevention and from 4 to 7% in patients with ICD for primary prevention. The aim of the ELECTRA registry is twofold:

1. 1.To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES.
2. 2.To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation; Defibrillators, Implantable

Keywords

Electrical storm

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Three years

Secondary Outcomes (1)

• Hospitalization for all causes

  Three years

Study Arms (1)

Electrical storm

Documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will be enrolled for a minimum of three years from the protocol approval. There is no pre-specified date for the end of enrollment, which will be decided by the study responsible according to the enrollment rate. A minimum of 500 patients will be included in the present registry. The exploratory nature intrinsic to the registry characteristics does not allow a sample size calculation by statistical means. However, the sample presented is based on the estimated enrolment rates of the participating centers during a 3-year enrolment period. Moreover, the sample size is large enough to postulate specific subgroup analyses.

You may qualify if:

• Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening.
• Age ≥18
• Written informed consent

You may not qualify if:

• patient without ICD
• Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect
• Inability to express an informed consent for the study

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital "Ospedali Riuniti"

Ancona, 60126, Italy

RECRUITING

Related Publications (6)

• Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD). Heart Rhythm. 2016 Oct;13(10):1987-92. doi: 10.1016/j.hrthm.2016.06.007. Epub 2016 Jun 9.

  PMID: 27291511 RESULT

• Guerra F, Flori M, Bonelli P, Patani F, Capucci A. Electrical storm and heart failure worsening in implantable cardiac defibrillator patients. Europace. 2015 Feb;17(2):247-54. doi: 10.1093/europace/euu298. Epub 2014 Oct 26.

  PMID: 25345831 RESULT

• Guerra F, Shkoza M, Scappini L, Flori M, Capucci A. Role of electrical storm as a mortality and morbidity risk factor and its clinical predictors: a meta-analysis. Europace. 2014 Mar;16(3):347-53. doi: 10.1093/europace/eut304. Epub 2013 Oct 4.

  PMID: 24096960 RESULT

• Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Pongetti G, Bonelli P, Patani F, Devecchi C, Accogli M, Occhetta E, Nigro G, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Cardiac resynchronization therapy and electrical storm: results of the OBSERVational registry on long-term outcome of ICD patients (OBSERVO-ICD). Europace. 2018 Jun 1;20(6):979-985. doi: 10.1093/europace/eux166.

  PMID: 28595339 RESULT

• Guerra F, Bonelli P, Flori M, Cipolletta L, Carbucicchio C, Izquierdo M, Kozluk E, Shivkumar K, Vaseghi M, Patani F, Cupido C, Pala S, Ruiz-Granell R, Ferrero A, Tondo C, Capucci A. Temporal Trends and Temperature-Related Incidence of Electrical Storm: The TEMPEST Study (Temperature-Related Incidence of Electrical Storm). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004634. doi: 10.1161/CIRCEP.116.004634.

  PMID: 28314850 RESULT

• Guerra F, Accogli M, Bonelli P, Carbucicchio C, Catto V, Cipolletta L, De Ferrari GM, Dell'Era G, Dusi V, Fabregat-Andres 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. doi: 10.1016/j.conctc.2017.06.002. eCollection 2017 Sep.

  PMID: 29696170 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Central Study Contacts

Federico Guerra, M.D.

CONTACT

+390715966593; f.guerra@univpm.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2021
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

IT (1)