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

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.