PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial

Jasper Boeddinghaus¹, Paolo Bima², Luca Crisanti³, Dagmar I Keller⁴, Ksenija Slankamenac⁴, Michael Christ⁵, Philipp Schuetz⁶, Andrea Wiencierz⁷, Ivo Strebel⁸, Julia Reinhardt⁸, Iryna Vyshnevska⁸, Tzu-Ying Tsao⁸, Felix Mahfoud⁸, Maria Pia Ruggieri⁹, Stephan Steuer¹⁰, Òscar Miró¹¹, Veli-Pekka Harjola¹², Fulvio Morello¹³, Peiman Nazerian¹⁴, Dominik Roth¹⁵, José Luis Zamorano¹⁶, Deborah Erica Gannon¹⁷, Jason Pott¹⁸, Mohammed Oa Abubakr¹⁹, Hyun Suk Yang²⁰, Joe Young²¹, Richina Bicette²¹, Andreea Cuculici²², Héctor Bueno²³, Juan Sanchis²⁴, Christian Mueller²⁵; PRESC1SE-MI investigators

Collaborators, Affiliations

Collaborators

PRESC1SE-MI investigators:
Doris Eis⁴, Stefan Venturini²⁶, Sebastian Haubitz²⁷, Angelika Hammerer-Lercher²⁷, Laurent Haegeli²⁷, Martin Schläpfer¹⁰, Simone Weisskopf¹⁰, Gemma Martínez-Nadal²⁸, Beatriz López-Barbeito²⁸, Johan Lassus²⁹, Kimmo Suojanen²⁹, Tomi Mäkiaho²⁹, Enrico Lupia³⁰, Silvia Tarditi³⁰, Giulia Labarile³⁰, Giuliano De Stefano¹⁴, Eduardo Del Gais¹⁴, Gianni Mecocci¹⁴, Maximilian Niederer¹⁵, Larissa Bernert¹⁵, Paloma Remior Perez¹⁶, Marcelo Sanmartín Fernánd¹⁶, Clemencia de Rueda Panadero¹⁶, Vanesa Santos Polo¹⁶, Virginia Gehrke³¹, Sharyl Dwyer³¹, Julie Goofruit³¹, Ben Bloom¹⁸, Raine Astin-Chamberlain¹⁸, Noemi Caponi¹⁸, Emily Campell¹⁸, Fatma Mohammed¹⁸, Nimca Omer¹⁸, Alison Quinn¹⁸, Jaqueline Sear¹⁸, Grace Tunesi¹⁸, Cristina Thiebaud¹⁹, Karen Hopkins¹⁹, Katie Morgan¹⁹, Kyeong Ryong Lee³², Mina Hur³², Frank W Peacock³³, Phong Huynh³³, Adriana Covaliov²², Ovidiu Chioncel²², Gabriele Valli³⁴, Francesca De Marco³⁴, M Lorena Castro Arias³⁵, Rodrigo Pacheco Puig³⁵, Guillermo Moreno³⁶, Berk Mehmet Feyzi³⁶, Jorge Velez Garcia³⁶, Agustín Fernández-Cisnal²⁴, Jose Noceda³⁷, Aura Winterhalder³⁸, Beate Hartmann³⁸, Lu Cheng³⁸, Laura Pedrini³⁸, Maximillian Mais³⁹, Marie Therese Niggemann³⁸, Luca Koechlin³⁸, Pedro Lopez-Ayala³⁸, David Santer³⁸, Tamar S Muench-Gerber³⁸, Ana Yufera Sanchez³⁸, Anna H Porwit³⁸, Nicholas L Mills⁴⁰, David Conen⁴¹, Christopher B Granger⁴², John Parissis⁴³

Affiliations

¹ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; BHF Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom. Electronic address: jasper.boeddinghaus@usb.ch.
² Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; Department of Medical Sciences, University of Torino and A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
³ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; Emergency Department, San Giovanni Addolorata Hospital, Rome, Italy.
⁴ Emergency Department, University Hospital Zurich, Zurich, Switzerland.
⁵ GREAT Network, Rome, Italy; Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
⁶ Medical University Department, Division of General Internal and Emergency Medicine, Aarau, Switzerland.
⁷ Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
⁸ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy.
⁹ Emergency Department, San Giovanni Addolorata Hospital, Rome, Italy.
¹⁰ Emergency Department, St Clara Hospital, Basel, Switzerland.
¹¹ GREAT Network, Rome, Italy; Emergency Department, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Catalonia, Spain.
¹² GREAT Network, Rome, Italy; Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
¹³ Department of Medical Sciences, University of Torino and A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
¹⁴ Department of Emergency Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
¹⁵ Medical University of Vienna, Department of Emergency Medicine, Vienna, Austria.
¹⁶ Department of Cardiology, University Hospital Ramón y Cajal, CiberCV, Madrid, Spain.
¹⁷ Emergency Department, St. Andrew's War Memorial Hospital, Brisbane, Queensland, Australia.
¹⁸ Emergency Department, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.
¹⁹ Department of Cardiology and Emergency Medicine, Royal Cornwall Hospitals NHS Trust, Treliske, United Kingdom.
²⁰ Department of Cardiovascular Medicine, Konkuk University School of Medicine, Seoul, South Korea.
²¹ Baylor College of Medicine, Department of Emergency Medicine, Houston, TX.
²² Emergency Institute for Cardiovascular Diseases 'Prof. Dr. C.C. Iliescu', Bucharest, Romania.
²³ Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital, Madrid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
²⁴ Cardiology Department, Hospital Clinico Universitario de Valencia, INCLIVA, University of Valencia, CIBERCV, Valencia, Spain.
²⁵ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.
²⁶ Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
²⁷ Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.
²⁸ Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
²⁹ Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
³⁰ Department of Medical Sciences, Università degli Studi di Torino and S.C. Medicina d'Urgenza U, A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
³¹ Emergency Department, St. Andrew's War Memorial Hospital, Brisbane, QLD, Australia.
³² Departments of Emergency Medicine and Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea.
³³ Baylor College of Medicine, Department of Emergency Medicine, Houston, Texas, USA.
³⁴ Department of Emergency Medicine, San Giovanni Addolorata Hospital, Rome, Italy.
³⁵ Emergency Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
³⁶ Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
³⁷ Emergency Department, Hospital Clinico Universitario de Valencia, INCLIVA, Valencia, Spain.
³⁸ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
³⁹ Emergency Department, University Hospital Zurich, Zurich, Switzerland; Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴⁰ BHF Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom.
⁴¹ Department of Cardiology, PHRI, McMaster University, Hamilton, Canada.
⁴² Department of Cardiology, Duke Clinical Research Institute; University of Durham, USA.
⁴³ Attikon General Hospital Athens, Greece.

PMID: 41177204
DOI: 10.1016/j.ahj.2025.107299

PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial

Jasper Boeddinghaus et al. Am Heart J. 2026 Feb.

. 2026 Feb:292:107299.

doi: 10.1016/j.ahj.2025.107299. Epub 2025 Oct 31.

Authors

Collaborators

PRESC1SE-MI investigators:
Doris Eis⁴, Stefan Venturini²⁶, Sebastian Haubitz²⁷, Angelika Hammerer-Lercher²⁷, Laurent Haegeli²⁷, Martin Schläpfer¹⁰, Simone Weisskopf¹⁰, Gemma Martínez-Nadal²⁸, Beatriz López-Barbeito²⁸, Johan Lassus²⁹, Kimmo Suojanen²⁹, Tomi Mäkiaho²⁹, Enrico Lupia³⁰, Silvia Tarditi³⁰, Giulia Labarile³⁰, Giuliano De Stefano¹⁴, Eduardo Del Gais¹⁴, Gianni Mecocci¹⁴, Maximilian Niederer¹⁵, Larissa Bernert¹⁵, Paloma Remior Perez¹⁶, Marcelo Sanmartín Fernánd¹⁶, Clemencia de Rueda Panadero¹⁶, Vanesa Santos Polo¹⁶, Virginia Gehrke³¹, Sharyl Dwyer³¹, Julie Goofruit³¹, Ben Bloom¹⁸, Raine Astin-Chamberlain¹⁸, Noemi Caponi¹⁸, Emily Campell¹⁸, Fatma Mohammed¹⁸, Nimca Omer¹⁸, Alison Quinn¹⁸, Jaqueline Sear¹⁸, Grace Tunesi¹⁸, Cristina Thiebaud¹⁹, Karen Hopkins¹⁹, Katie Morgan¹⁹, Kyeong Ryong Lee³², Mina Hur³², Frank W Peacock³³, Phong Huynh³³, Adriana Covaliov²², Ovidiu Chioncel²², Gabriele Valli³⁴, Francesca De Marco³⁴, M Lorena Castro Arias³⁵, Rodrigo Pacheco Puig³⁵, Guillermo Moreno³⁶, Berk Mehmet Feyzi³⁶, Jorge Velez Garcia³⁶, Agustín Fernández-Cisnal²⁴, Jose Noceda³⁷, Aura Winterhalder³⁸, Beate Hartmann³⁸, Lu Cheng³⁸, Laura Pedrini³⁸, Maximillian Mais³⁹, Marie Therese Niggemann³⁸, Luca Koechlin³⁸, Pedro Lopez-Ayala³⁸, David Santer³⁸, Tamar S Muench-Gerber³⁸, Ana Yufera Sanchez³⁸, Anna H Porwit³⁸, Nicholas L Mills⁴⁰, David Conen⁴¹, Christopher B Granger⁴², John Parissis⁴³

Affiliations

¹ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; BHF Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom. Electronic address: jasper.boeddinghaus@usb.ch.
² Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; Department of Medical Sciences, University of Torino and A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
³ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy; Emergency Department, San Giovanni Addolorata Hospital, Rome, Italy.
⁴ Emergency Department, University Hospital Zurich, Zurich, Switzerland.
⁵ GREAT Network, Rome, Italy; Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
⁶ Medical University Department, Division of General Internal and Emergency Medicine, Aarau, Switzerland.
⁷ Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
⁸ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy.
⁹ Emergency Department, San Giovanni Addolorata Hospital, Rome, Italy.
¹⁰ Emergency Department, St Clara Hospital, Basel, Switzerland.
¹¹ GREAT Network, Rome, Italy; Emergency Department, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Catalonia, Spain.
¹² GREAT Network, Rome, Italy; Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
¹³ Department of Medical Sciences, University of Torino and A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
¹⁴ Department of Emergency Medicine, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
¹⁵ Medical University of Vienna, Department of Emergency Medicine, Vienna, Austria.
¹⁶ Department of Cardiology, University Hospital Ramón y Cajal, CiberCV, Madrid, Spain.
¹⁷ Emergency Department, St. Andrew's War Memorial Hospital, Brisbane, Queensland, Australia.
¹⁸ Emergency Department, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.
¹⁹ Department of Cardiology and Emergency Medicine, Royal Cornwall Hospitals NHS Trust, Treliske, United Kingdom.
²⁰ Department of Cardiovascular Medicine, Konkuk University School of Medicine, Seoul, South Korea.
²¹ Baylor College of Medicine, Department of Emergency Medicine, Houston, TX.
²² Emergency Institute for Cardiovascular Diseases 'Prof. Dr. C.C. Iliescu', Bucharest, Romania.
²³ Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Cardiology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital, Madrid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares (CIBERCV), Madrid, Spain; Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
²⁴ Cardiology Department, Hospital Clinico Universitario de Valencia, INCLIVA, University of Valencia, CIBERCV, Valencia, Spain.
²⁵ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland; GREAT Network, Rome, Italy. Electronic address: christian.mueller@usb.ch.
²⁶ Emergency Department, Kantonsspital Luzern, Lucerne, Switzerland.
²⁷ Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.
²⁸ Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
²⁹ Department of Emergency Medicine and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
³⁰ Department of Medical Sciences, Università degli Studi di Torino and S.C. Medicina d'Urgenza U, A.O.U., Città della Salute e della Scienza Hospital, University of Torino, Torino, Italy.
³¹ Emergency Department, St. Andrew's War Memorial Hospital, Brisbane, QLD, Australia.
³² Departments of Emergency Medicine and Laboratory Medicine, Konkuk University School of Medicine, Seoul, South Korea.
³³ Baylor College of Medicine, Department of Emergency Medicine, Houston, Texas, USA.
³⁴ Department of Emergency Medicine, San Giovanni Addolorata Hospital, Rome, Italy.
³⁵ Emergency Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
³⁶ Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
³⁷ Emergency Department, Hospital Clinico Universitario de Valencia, INCLIVA, Valencia, Spain.
³⁸ Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
³⁹ Emergency Department, University Hospital Zurich, Zurich, Switzerland; Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴⁰ BHF Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom.
⁴¹ Department of Cardiology, PHRI, McMaster University, Hamilton, Canada.
⁴² Department of Cardiology, Duke Clinical Research Institute; University of Durham, USA.
⁴³ Attikon General Hospital Athens, Greece.

PMID: 41177204
DOI: 10.1016/j.ahj.2025.107299

Abstract

Background: International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy.

Methods: PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic acute chest discomfort and suspected MI presenting to the Emergency Department (ED) will be enrolled. Sites still using the ESC 0/3h-algorithm as standard-of-care will be randomized to implement the more rapid ESC 0/1h-algorithm at an early or late implementation step. During the validation phase, participating sites continue to use the ESC 0/3h-algorithm. The co-primary outcomes are a composite of type 1 MI or all-cause death at 30 days (safety), and the length of stay in the ED (efficacy). The trial is designed to show noninferiority for safety and superiority for efficacy, with a power of at least 90%.

Conclusions: PRESC1SE-MI is the largest international multicenter trial to date evaluating the safety and the efficacy of the implementation of the more rapid ESC 0/1h-algorithm at late adopting centers across multiple countries and healthcare systems. Its findings have the potential to improve patient care and reduce healthcare costs.

Trial registration: https://clinicaltrials.gov/study/NCT05649384.

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Conflict of interest statement

Conflict of interest Drs. Boeddinghaus and Mueller designed the study, wrote the paper, and decided to publish the trial design. All authors have read and approved the manuscript. The sponsors had no role in designing or conducting the study and have no role in gathering or analyzing the data. The manuscript and its contents have not been published previously and are not being considered for publications elsewhere in whole or in part in any language, including publicly accessible web sites or e-print servers. We disclose that Dr. Boeddinghaus is supported by an Edinburgh Doctoral College Scholarship and research grants from the University of Basel, the University Hospital of Basel, the Division of Internal Medicine, the Swiss Academy of Medical Sciences, the Gottfried and Julia Bangerter-Rhyner Foundation, the Swiss National Science Foundation, the Swiss Heart Foundation, and has received honoraria from Siemens, Roche Diagnostics, Ortho Clinical Diagnostics, Quidel Corporation, and Beckman Coulter, and travel support from Medtronic and Vascularmedical, all outside the submitted work. Dr. Bima received a grant from the Swiss Heart Foundation (FF23062) and receives consulting fees from Scandinavian CRO (SCRO, part of Aurevia), all outside the submitted work. Outside of this study, Dr. Bueno receives research funding from the European Union (EU4H-2022-JA-03), Instituto de Salud Carlos III, Spain (FORTALECE program, PI21/01572), Sociedad Española de Cardiología, AstraZeneca, Boehringer Ingelheim, and Janssen; and has received in the past consulting/speaking fees from Novo Nordisk and Organon. Enrico Lupia and Fulvio Morello are supported by the Fondazione Ricerca Molinette (grant 2023 to EL) and the Università degli Studi di Torino (MORF_RILO_21_02 and 23_03, to FM). Dr. Mueller has received research support from the Swiss National Science Foundation, the Swiss Heart Foundation, Innosuisse, the University of Basel, the University Hospital Basel, Abbott, Astra Zeneca, Beckman Coulter, Biomerieux, Boehringer Ingelheim, Idorsia, Novartis, Ortho Cinical Diagnostics, Quidel, Roche, Siemens, Singulex, SpinChip, Sphingotec, as well as speaker honoraria/consulting honoraria from Abbott, Acon, Amgen, Astra Zeneca, Boehringer Ingelheim, Bayer, BMS, Idorsia, Novartis, Osler, Roche, SpinChip, and Sanofi, outside of the submitted work. All other authors declare that they have no conflict of interest with this study.

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PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial

Collaborators

Affiliations

PRospective evaluation of the European Society of Cardiology 0/1h-algorithm`s safety and efficacy for triage of patients with suspected myocardial infarction (PRESC1SE-MI): Rationale and design of a prospective international multicenter stepped-wedge cluster randomized controlled trial

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

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Associated data

LinkOut - more resources

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