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PERFORM-TSIX (clinicaltrials.gov identifier: NCT06734117) is a prospective, international, observational, longitudinal cohort study to evaluate the clinical performance of the next-generation Elecsys\u00ae Troponin T hs Gen 6 assay; the study design is presented here.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats: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\u00a0h 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\u00a0days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>PERFORM\u2013TSIX enrolled 5631 participants across 50 sites from the USA, Europe, China, and Japan. Patients aged\u2009\u2265\u200920\u00a0years 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats: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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00392-025-02842-x","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T10:29:20Z","timestamp":1768818560000},"page":"1807-1818","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical performance of the next generation Elecsys Troponin T high-sensitivity Gen 6 assay in acute coronary syndrome (PERFORM-TSIX): study design"],"prefix":"10.1007","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4841-9922","authenticated-orcid":false,"given":"Lori B.","family":"Daniels","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Giannitsis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Mueller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven J. 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He serves as a consultant for Roche Diagnostics, BRAHMS Thermo Fisher Scientific, and Boehringer Ingelheim and has received research funding from BRAHMS Thermo Fisher Scientific, Roche Diagnostics, Bayer Vital, and Daiichi Sankyo.CM reports research support from the Swiss National Science Foundation, the Swiss Heart Foundation, the University of Basel, the University Hospital Basel, the KTI, Abbott, Beckman Coulter, BRAHMS, Idorsia, Ortho Diagnostics, Novartis, Roche, Siemens, and Singulex, and speaker\/consulting honoraria from Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Idorsia, Novartis, Osler, Roche, and Sanofi, all outside the submitted work.SJRM reports research support and consulting honoraria from Abbott Laboratories and Roche Diagnostics, and lecture fees from Werfen, all paid to the institution.DB and DK are employees of Roche Diagnostics International AG.GB is an employee of Roche Diagnostics GmbH and holds stock in F Hoffmann-La Roche.MC is an employee of Roche Molecular Systems, Inc. and holds stock in F Hoffmann-La Roche.RB has consulted for Siemens, Roche, Beckman, Singulex, LumiraDx, Radiometer, and Abbott, and has received research support from Roche, Abbott, Siemens, Singulex, and LumiraDx.RC is a consultant for and receives funding\/support from Roche Diagnostics, Siemens Healthineers, Beckman Coulter Diagnostics, Becton Dickinson and Company, QuidelOrtho Corp., and Sphingotec GmbH.CC states no conflict of interest related to this study and declares to have a research collaboration with Roche Diagnostics and received lecture fees, all fully used for further research on cardiac biomarkers.CRdF reported receiving grants from Roche Diagnostics, QuidelOrtho, Siemens Healthineers, FujiRebio, and Abbott Diagnostics; receiving personal fees from Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers, QuidelOrtho, Tosoh, and FujiRebio; and holding a patent that assesses differential risk for developing heart failure.KME reported receiving personal fees from Roche Diagnostics.KI received a research grant from Grant-in-Aid for Scientific Research C (No. 18K09954), Roche Diagnostics, SB Bioscience Co., Ltd., Fujirebio Inc., Bayel Sysmex, and Kanto Chemical Co., Inc.ASJ has consulted or presently consults for most of the major diagnostics companies, including Abbott, Siemens, ET Healthcare, Roche, Radiometer, Mindray, 4Teen4, and Moderna. He has stock options in RCE Technologies.CPM has recieved a grant from the National Heart, Lung, And Blood Institute (K23HL167659) and has received personal fees or honorarium from Roche Diagnostics, Abbott Laboratories, Alnylam Pharmaceuticals, Cleerly Health, Corcept Therapeutics, New Amsterdam Pharma, and HeartFlow.JM receives research funding\/support from Beckman Coulter, Roche Diagnostics, Abbott Laboratories, Polymedco, and Siemens. He is a consultant for Beckman Coulter, Roche Diagnostics, Polymedco, and Siemens.JTN reported receiving personal fees from Roche, Siemens, Abbott, and PHC; having a patent pending on the use of a computing device to estimate the probability of myocardial infarction; and being a co-founder and shareholder of ART-EMIS Hamburg GmbH.TO reported receiving personal fees from Abbott Laboratories, Roche Diagnostics, CardiNor, SpinChip, and Novo Nordisk; receiving grants from Abbott Laboratories; and receiving nonfinancial support from Roche Diagnostics, Novartis, ChromaDex Inc., a Niagen Bioscience company, and CardiNor.CP reported receiving speaker and advisory board fees from Roche Diagnostics and Abbott Diagnostics.YS reported receiving consulting fees from Abbott Vascular, Boston Scientific, CathWorks, GE Healthcare, HeartFlow, Philips, Roche Diagnostics, and Siemens; receiving speaker fees from Abbott Vascular, CathWorks, Cleerly, GE Healthcare, HeartFlow, Medtronic, Philips, and Roche Diagnostics; advisory board fees from Abbott Vascular, GE Healthcare, HeartFlow, Philips, Roche Diagnostics, and Siemens; a research grant from Cleerly and an educational grant from Shockwave Medical. He and others hold patent 20210401347.JWCT has received honoraria from Amgen, Medtronic, Abbott Vascular, Novartis, Biosensors; research and educational grants from Medtronic, Edwards, Abbott, Menarini, Roche; and consulting fees from J&J, Medtronic.MPT has received research and education grants from Abbott, Alere, Beckman Coulter, QuidelOrtho, Radiometer, Roche, and Siemens Healthineers. He has received consultant, speaker, and\/or advisory board payments from Abbott, Alere, Beckman Coulter, QuidelOrtho, Radiometer, Roche, Siemens Healthineers, and Upstream Medical Technologies.RT reported receiving grants from the German Center for Cardiovascular Research, the K\u00fchne Foundation, the Joachim Herz Foundation, the Swiss National Science Foundation, and the Swiss Heart Foundation; receiving personal fees from Abbott, Amgen, AstraZeneca, Psyros, Roche, Siemens Healthineers, Singulex, and Thermo Scientific BRAHMS Biomarkers; having a patent pending on the use of a computing device to estimate the probability of myocardial infarction; and being a co-founder and shareholder of ART-EMIS Hamburg GmbH.NLM is supported by the British Heart Foundation through a Chair Award (CH\/F\/21\/90010), a Programme Grant (RG\/F\/25\/110169), and a Research Excellence Award (RE\/24\/130012). They report receiving honoraria or speaker fees from Abbott Diagnostics, Siemens Healthineers, and Roche Diagnostics within the last 3\u00a0years.WFP is a consultant for Brainbox, Abbott, Werfen, Janssen, Osler, Roche, Siemens, CSL Behring, RCE Technologies, Trivarum, Upstream, and ScPharma. He has an ownership interest in Aseptoscope, Emergencies in Medicine, and Comprehensive Research Associates.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"ELECSYS and COBAS are trademarks of Roche.All other product names and trademarks are the property of their respective owners.","order":2,"name":"Ethics","label":"Disclaimer","group":{"name":"EthicsHeading","label":"Declarations"}}]}}