Evidence map›Paper›PMID 41553478›Full record

Observational studyClinical research in cardiology : official journal of the German Cardiac Society2026

Clinical performance of the next generation Elecsys Troponin T high-sensitivity Gen 6 assay in acute coronary syndrome (PERFORM-TSIX): study design.

Lori B Daniels, Evangelos Giannitsis, Christian Mueller, Steven J R Meex, David Buehlmann, Dunja Kurtoic, Garnet Bendig, Mette Cole, Richard Body, Robert H Christenson and 17 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Clinical research in cardiology : official journal of the German Cardiac Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06734117 (Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06734117 completednot on this map

Clinical Performance of Elecsys® Troponin T hs Gen 6 in Subjects With Symptoms of Acute Coronary Syndrome

TypeobservationalSponsorHoffmann-La RocheRan2021 to 2024Enrolled5,429ConditionsAcute Coronary Syndrome, Myocardial InfarctionArmsElecsys® Troponin T hs Gen 6, Blood sample collection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Lori B DanielsDivision of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA, USA. lbdaniels@health.ucsd.edu.ORCID http://orcid.org/0000-0002-4841-9922
Evangelos GiannitsisDepartment of Internal Medicine III, Cardiology University Hospital of Heidelberg, Heidelberg, Germany.
Christian MuellerCardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
Steven J R MeexCentral Diagnostic Laboratory, Maastricht University Medical Center, Maastricht, the Netherlands.
David BuehlmannClinical Development, Roche Diagnostics International AG, Rotkreuz, Switzerland.
Dunja KurtoicBiostatistics, Roche Diagnostics International AG, Rotkreuz, Switzerland.
Garnet BendigClinical Operations, Roche Diagnostics GmbH, Penzberg, Germany.
Mette ColeClinical Operations, Roche Molecular Systems, Inc., Indianapolis, IN, USA.
Richard BodyEmergency Department, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Robert H ChristensonDepartment of Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.
Christa CobbaertDepartment of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Christopher R deFilippiDepartments of Medicine and Pathology, University of Maryland School of Medicine, Baltimore, MD, USA.
Kai M EggersDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden.
Kenji InoueTokyo Heart Rhythm Clinic Shinjuku, Tokyo, Japan.
Allan S JaffeDepartment of Cardiovascular Medicine and Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Cian P McCarthyHeart and Vascular Institute, Massachusetts General Brigham and Harvard Medical School, Boston, MA, USA.
James McCordHeart and Vascular Institute, Henry Ford Health, Detroit, MI, USA.
Johannes T NeumannDepartment of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Torbjørn OmlandDepartment of Cardiology, Akershus University Hospital, Lørenskog, Norway.
Cynthia PapendickDepartment of Emergency Medicine, The Royal Adelaide Hospital, Central Adelaide Local Health Network, Adelaide, South Australia, Australia.
Yader SandovalMinneapolis Heart Institute, Abbott Northwestern Hospital and Center for Coronary Artery Disease, Minneapolis Heart Institute Foundation, Minneapolis, MN, USA.
Jack Wei Chieh TanNational Heart Centre Singapore, 5 Hospital Dr, Singapore, 169609, Singapore.
Martin P ThanDepartment of Emergency Medicine, Christchurch Hospital, Christchurch, New Zealand.
Raphael TwerenboldDepartment of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Nicholas L MillsBritish Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
W Frank PeacockDepartment of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.
TSIX investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh-sensitivity cardiac troponin (hs-cTn) assays are the gold standard for the early diagnosis and risk stratification of acute myocardial infarction (AMI). PERFORM-TSIX (clinicaltrials.gov identifier: NCT06734117) is a prospective, international, observational, longitudinal cohort study to evaluate the clinical performance of the next-generation Elecsys® Troponin T hs Gen 6 assay; the study design is presented here.

objectivesThe primary objective is to determine the sensitivity of the Troponin T hs Gen 6 assay for the detection of centrally adjudicated AMI diagnosis at 3 h post-emergency department (ED) presentation. Secondary objectives include evaluation of clinical performance at 0, 1-, 5-, and 6-h post-ED presentation and validation of thresholds for a 0/1-h algorithm to rule out AMI. Exploratory objectives include validation of thresholds for a 0/1-h algorithm to rule in AMI and a 0/2-h algorithm to rule in/out AMI and evaluation of prognostic performance at 30 and 180 days.

methodsPERFORM-TSIX enrolled 5631 participants across 50 sites from the USA, Europe, China, and Japan. Patients aged ≥ 20 years presenting to the ED with symptoms/signs of acute coronary syndrome were enrolled. All patients were required to have cTn measured as part of their routine care; AMI diagnosis was adjudicated by an independent clinical events committee in accordance with the Fourth Universal Definition of MI, blinded to the results of the Troponin T hs Gen 6 assay.

conclusionPERFORM-TSIX will determine the clinical performance of the Troponin T hs Gen 6 assay for the diagnosis of AMI in a large, diverse global population.

Indexed as

Acute Coronary SyndromeMyocardial InfarctionTroponin TAgedAlgorithmsBiomarkersEarly DiagnosisFemaleHumansLongitudinal StudiesMaleMiddle AgedPredictive Value of TestsPrognosisProspective StudiesReproducibility of ResultsBiomarkersTroponin TAcute coronary syndromeAcute myocardial infarctionDiagnosisHigh-sensitivity cardiac troponin TProtocolRisk stratification

Identifiers

PMID41553478
PMCPMC13562094

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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.