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Background <p>High-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.</p> Objectives <p>The 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&#xa0;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&#xa0;days.</p> Methods <p>PERFORM–TSIX enrolled 5631 participants across 50 sites from the USA, Europe, China, and Japan. Patients aged ≥ 20&#xa0;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.</p> Conclusion <p>PERFORM-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.</p> Graphical Abstract <p></p>

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

  • 期刊论文

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  • 发表日期：

    2026年1月19日

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  • Lori B. Daniels,
  • Evangelos Giannitsis,
  • Christian Mueller,
  • Steven J. R. Meex,
  • David Buehlmann,
  • Dunja Kurtoic,
  • Garnet Bendig,
  • Mette Cole,
  • Richard Body,
  • Robert H. Christenson,
  • Christa Cobbaert,
  • Christopher R. deFilippi,
  • Kai M. Eggers,
  • Kenji Inoue,
  • Allan S. Jaffe,
  • Cian P. McCarthy,
  • James McCord,
  • Johannes T. Neumann,
  • Torbjørn Omland,
  • Cynthia Papendick,
  • Yader Sandoval,
  • Jack Wei Chieh Tan,
  • Martin P. Than,
  • Raphael Twerenbold,
  • Nicholas L. Mills,
  • W. Frank Peacock,
  • Michael B Jacobs,
  • Gregg Lucksinger,
  • Richard Powell,
  • Daniel Johnson,
  • Hugh Coleman,
  • Melanie Fein,
  • Joseph Surber,
  • Jack Vu,
  • Michael Hassman,
  • John Hernandez,
  • Judith Kirstein,
  • Christian Tomaszewski,
  • Michael Runyon,
  • Jonathan Gong,
  • David Wein,
  • Sara Andrabi,
  • David Kopin,
  • Germain Larrain,
  • Naheem Tahirkheli,
  • Brian Clemency,
  • Shuaib Abdullah,
  • Ravi Hira,
  • Howard Klausner,
  • Simon Mahler,
  • Chad Crystal,
  • Gary Headden,
  • Peter Chaille,
  • Chad Cannon,
  • Alexander Limkakeng,
  • Vaishal Tolia,
  • Barry Knapp,
  • Mohammad Massoomi,
  • Yader Sandoval,
  • Alexander Limkakeng,
  • Emily Ko,
  • Brian Clemency,
  • Veronica Luzzi,
  • Robert Christenson,
  • Nam Tran,
  • Jennifer Powers Carson,
  • Jan Niederdöckl,
  • Filippo Cacioppo,
  • Emil Kolev,
  • Todor Popov,
  • Andrey Petrov,
  • Dobri Hazarbasanov,
  • lana Simova,
  • Luci Suganthi Magimaiseelan,
  • Christine Kosch,
  • Gernot Klein,
  • Kai Mehltretter,
  • Joachim Sauter,
  • Sybille Baumann,
  • Martin Moeckel,
  • Raphael Twerenbold,
  • Matthias Müller-Hennessen,
  • Moritz Biener,
  • Peter Findeisen,
  • Volkher Scharnhorst,
  • Torbjøm Omland,
  • Urszula Wilczek-Kosowska,
  • Ewa Zimmer-Satora,
  • Ewa Krecipro-Nizińska,
  • Oscar Mirö,
  • Victor Jiménez Diaz,
  • Christian Mueller,
  • Michael Christ,
  • Stephen Lynch,
  • Rick Body,
  • Shunji Matsuki,
  • Takashi Eto,
  • Takanori Tanaka,
  • Ryuzo Hanada,
  • Takuo Nakagami,
  • Tatsuya Nakama,
  • Kazushige Kadota,
  • Shan Jing,
  • Shuwen Yu,
  • Hongxuan Zhang,
  • Jun Zhang,
  • Yong Huo,
  • Yan Zhang,
  • Li Yan,
  • Longyuan Jiang,
  • Weiqiang Chen,
  • Jianying Huang,
  • Yan Zhao,
  • Ling Guan,
  • Yanhua Yang,
  • Qin Zhang,
  • Zhaohui Qiu

摘要

Background

High-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.

Objectives

The 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.

Methods

PERFORM–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.

Conclusion

PERFORM-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.

Graphical Abstract