Clinical performance of the next generation Elecsys Troponin T high-sensitivity Gen 6 assay in acute coronary syndrome (PERFORM-TSIX): study design
Year: 2026
Type: article
Abstract: 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.
Source: Clinical Research in Cardiology
Authors: 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, on behalf of the TSIX investigators, 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
Institutions: University of California San Diego, Heidelberg University, University Hospital Heidelberg, University of Basel, University Hospital of Basel, Maastricht University Medical Centre, Maastricht University, Roche (Switzerland), Roche Diagnostics International AG (Switzerland), Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, University of Maryland, Baltimore, Leiden University Medical Center, Uppsala University, Juntendo University, Mayo Clinic, Harvard University, Mass General Brigham, Henry Ford Health, Henry Ford Hospital, Universität Hamburg, University Medical Center Hamburg-Eppendorf, German Centre for Cardiovascular Research, Monash University, University of Oslo, Akershus University Hospital, Royal Adelaide Hospital, Central Adelaide Local Health Network, The University of Adelaide, Abbott Northwestern Hospital, Minneapolis Heart Institute Foundation, Duke-NUS Medical School, National Heart Centre Singapore, Sengkang General Hospital, Christchurch Hospital, University of Kansas Medical Center, University of Otago, British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Baylor College of Medicine
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
OpenAlex ID: W7124732932