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Arrhythmias, CardiacELECTRANCT02882139

International Electrical Storm Registry

An observational study of Arrhythmias, Cardiac and Tachycardia, Ventricular, run by Università Politecnica delle Marche at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
500 participants
Where
1 siteItaly
Study dates
Aug 2016to Aug 2021
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Federico Guerra, M.D. contact

+390715966593

f.guerra@univpm.it

Italy1 site, 1 recruiting

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

    Ancona, 60126

    Paolo Bonelli, MD, +390715966593, electraregistry@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Multicenter Registry on Patients Affected by Electrical Storm

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.

Read more

The aim of the ELECTRA registry is twofold:

  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. To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.
Keywords
Electrical storm
Medical subject headings
Arrhythmias, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02882139
Study groupRoleWhat they receive
Electrical stormDocumentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: Three years

Secondary outcomes (1)

  1. Hospitalization for all causes

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2019 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02882139
Sponsor's protocol ID
2016-0364 OR
Acronym
ELECTRA
Status last verified
Oct 2018
First submitted
24 Aug 2016
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27291511

  • 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.

    PubMed 25345831

  • 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.

    PubMed 24096960

  • 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.

    PubMed 28595339

  • 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.

    PubMed 28314850

  • 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.

    PubMed 29696170

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmias, Cardiac and Tachycardia, Ventricular, run by Università Politecnica delle Marche at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Federico Guerra, M.D. (+390715966593, f.guerra@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02882139, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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