Evidence map›Paper›PMID 22117037›Full record

ArticleEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2012

Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype.

Joachim Seegers, Marc A Vos, Panagiota Flevari, Rik Willems, Christian Sohns, Dirk Vollmann, Lars Lüthje, Dimitrios T Kremastinos, Vincent Floré, Mathias Meine and 9 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01209494 completednot on this map

The EU TrigTreat Clinical Study: An Advanced Diagnostics and Observational Trial for Arrhythmia Risk Stratification and Correlation With Genotype

TypeobservationalSponsorUniversity Medical Center GoettingenRan2010 to 2014Enrolled672ConditionsCardiomyopathies, Primary, Arrhythmia, Sudden Cardiac Death, Calcium Metabolism Disorders
NCT02064192 completednot on this mapstarted 2014, after this paper: background citation

Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

TypeobservationalSponsorUniversity Medical Center GoettingenRan2014 to 2019Enrolled2,285ConditionsCoronary Artery Disease, Myocardial Infarction, Dilated Cardiomyopathy, Implantable Defibrillator User
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Repeating noninvasive risk stratification improves prediction of outcome in ICD patients.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2020
    Article
  2. Review
  3. Article
  4. Article
  5. Implementation of guidelines for implantable cardioverter-defibrillator therapy in clinical practice: Which patients do benefit?Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2013
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Joachim SeegersDepartment of Cardiology and Pneumology, University Medical Centre Göttingen, Georg-August-Universität, Göttingen, Germany.
Marc A Vos
Panagiota Flevari
Rik Willems
Christian Sohns
Dirk Vollmann
Lars Lüthje
Dimitrios T Kremastinos
Vincent Floré
Mathias Meine
Anton Tuinenburg
Rachel C Myles
Dirk Simon
Jürgen Brockmöller
Tim Friede
Gerd Hasenfuß
Stephan E Lehnart
Markus Zabel
EUTrigTreat Clinical Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe EUTrigTreat clinical study has been designed as a prospective multicentre observational study and aims to (i) risk stratify patients with an implantable cardioverter defibrillator (ICD) for mortality and shock risk using multiple novel and established risk markers, (ii) explore a link between repolarization biomarkers and genetics of ion (Ca(2+), Na(+), K(+)) metabolism, (iii) compare the results of invasive and non-invasive electrophysiological (EP) testing, (iv) assess changes of non-invasive risk stratification tests over time, and (v) associate arrythmogenomic risk through 19 candidate genes. METHODS AND

resultsPatients with clinical ICD indication are eligible for the trial. Upon inclusion, patients will undergo non-invasive risk stratification, including beat-to-beat variability of repolarization (BVR), T-wave alternans, T-wave morphology variables, ambient arrhythmias from Holter, heart rate variability, and heart rate turbulence. Non-invasive or invasive programmed electrical stimulation will assess inducibility of ventricular arrhythmias, with the latter including recordings of monophasic action potentials and assessment of restitution properties. Established candidate genes are screened for variants. The primary endpoint is all-cause mortality, while one of the secondary endpoints is ICD shock risk. A mean follow-up of 3.3 years is anticipated. Non-invasive testing will be repeated annually during follow-up. It has been calculated that 700 patients are required to identify risk predictors of the primary endpoint, with a possible increase to 1000 patients based on interim risk analysis.

conclusionThe EUTrigTreat clinical study aims to overcome current shortcomings in sudden cardiac death risk stratification and to answer several related research questions. The initial patient recruitment is expected to be completed in July 2012, and follow-up is expected to end in September 2014. Clinicaltrials.gov identifier: NCT01209494.

Indexed as

Clinical Trials as TopicGenotypeMulticenter Studies as TopicResearch DesignArrhythmias, CardiacCalciumCause of DeathDefibrillators, ImplantableElectrophysiologic Techniques, CardiacFemaleHeart RateHumansMalePotassiumRiskSodiumCalciumPotassiumSodium

Identifiers

PMID22117037
PMCPMC3283222

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.