Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

NCT05649384 | Active Not Recruiting DMC

• 2 other identifiers: 2019-022692019
• Study Type: interventional
• Target: 64,374
• Locations: 10 countries
• Sites: 19

Brief Summary

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

Conditions

Acute Chest Pain; NSTEMI - Non-ST Segment Elevation MI

Keywords

ESC 0/1-hour algorithm; Emergency department; Chest pain; Chest discomfort; Myocardial Infarction MI; Acute Myocardial Infarction AMI; Acute Coronary Syndrome ACS; NSTEMI Non-ST-segment elevation myocardial infarction; NSTE-ACS Non-ST-segment elevation acute coronary syndrome; Unstable angina; Damaged muscle of the heart; Cardiac Biomarkers; Cardiac Troponin T cTnT; Cardiac-Specific Troponin T; Cardiac Troponin I cTnI; Cardiac-Specific troponin I; Amount of troponin in the bloodstream; Increased troponin level; Elevated troponin level; High troponin level; Troponin assessment; Measurement of troponin levels; High-sensitive troponin test; High-sensitivity troponin T testing; High-sensitive Troponin T hsTnT; cTnT-hs; High-sensitive Troponin I hsTnI; cTnI-hs; High-sensitivity cardiac troponin assays; ED presentation; ED admission; ED work-up; Triage emergency department; Triage emergency room; Triage emergency hospital; Rapid Rule-out of Acute Myocardial Infarction; Shorter stay in the emergency department; ESC 0/3-hour algorithm; ESC Guidelines; European Guidelines; 0/1-hour algorithm; 0/3-hour algorithm

Outcome Measures

Primary Outcomes (2)

• Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation

  Mortality rate and number of newly diagnosed AMI (type 1) in all enrolled patients

  30 days

• Time from ED presentation to ED discharge or transfer

  Length of stay in the ED measured in hours

  30 days

Secondary Outcomes (13)

• Proportion of patients managed as outpatients

  24 hours

• Readmission for suspected AMI within 30 days after index presentation

  30 days

• All-cause mortality at 30 days in all patients

  30 days

• All-cause mortality at 365 days in all patients

  365 days

• New AMI (type1) at 30 days in all patients

  30 days

Study Arms (2)

0/1-hour algorithm

EXPERIMENTAL

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.

Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm

0/3-hour algorithm

ACTIVE COMPARATOR

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.

Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm

Interventions

European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm DIAGNOSTIC_TEST

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.

Also known as: 0/1-hour algorithm

0/1-hour algorithm

European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm DIAGNOSTIC_TEST

High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.

Also known as: 0/3-hour algorithm

0/3-hour algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above
• Presentation with acute non-traumatic acute chest pain to the emergency department
• Suspicion of acute myocardial infarction

You may not qualify if:

• Terminal kidney failure requiring dialysis
• Cardiac arrest
• Cardiogenic shock

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (20)

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

St Andrew's War Memorial Hospital Brisbane

Brisbane, Australia

Location

Vienna General Hospital (AKH Wien)

Vienna, Austria

Location

University Central Hospital Helsinki

Helsinki, Finland

Location

Attikon General Hospital Athens

Athens, Greece

Location

Careggi University Hospital Florence

Florence, Italy

Location

Azienda Ospedaliera San Giovanni Addolorata

Roma, Italy

Location

Hospital Città della Salute e della Scienza di Torino

Torino, Italy

Location

Emergency Institute for Cardiovascular Diseases C.C. Iliescu

Bucharest, Romania

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

University Hospital October 12 Madrid

Madrid, Spain

Location

University Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Clínico Universitario Valencia

Valencia, Spain

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

St. Claraspital

Basel, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Royal London Hospital

London, United Kingdom

Location

Royal Cornwall Hospitals Treliske

Truro, United Kingdom

Location

Related Publications (2)

• Boeddinghaus J, Bima P, Crisanti L, Keller DI, Slankamenac K, Christ M, Schuetz P, Wiencierz A, Strebel I, Reinhardt J, Vyshnevska I, Tsao TY, Ruggieri MP, Steuer S, Miro O, Harjola VP, Morello F, Nazerian P, Roth D, Zamorano JL, Gannon DE, Pott J, Bloom B, Zubaid R, Bicette R, Cuculici A, Bueno H, Sanchis J, Mahfoud F, Abubakr MOA, Yang HS, Mueller C; PRESC1SE-MI investigators. Safety and efficacy of the 0/1 h pathway for myocardial infarction in the emergency department: an international, pragmatic, stepped-wedge, cluster-randomised, controlled trial. Lancet. 2026 Aug 29:S0140-6736(26)01654-5. doi: 10.1016/S0140-6736(26)01654-5. Online ahead of print.

  PMID: 42667934 DERIVED

• Boeddinghaus J, Bima P, Crisanti L, Keller DI, Slankamenac K, Christ M, Schuetz P, Wiencierz A, Strebel I, Reinhardt J, Vyshnevska I, Tsao TY, Mahfoud F, Ruggieri MP, Steuer S, Miro O, Harjola VP, Morello F, Nazerian P, Roth D, Zamorano JL, Gannon DE, Pott J, Abubakr MO, Yang HS, Young J, Bicette R, Cuculici A, Bueno H, Sanchis J, Mueller C; PRESC1SE-MI investigators. 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. Am Heart J. 2026 Feb;292:107299. doi: 10.1016/j.ahj.2025.107299. Epub 2025 Oct 31.

  PMID: 41177204 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Emergencies; Chest Pain; Myocardial Infarction; Angina, Unstable

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes; Pain; Neurologic Manifestations; Signs and Symptoms; Angina Pectoris

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Christian Müller, MD Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Jasper Boeddinghaus, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective stepped-wedge cluster randomised controlled trial, sites are randomly assigned to either early initiation or late initiation of the ESC hs-cTnT/I 0/1h-algorithm and compared to the standard of care ESC hs-cTnT/I 0/3h-algorith

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 14, 2022
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication and ending 1 year after publication.
• Access Criteria: Requests to access de-identified individual participant data that underlie the results reported in this Article for academic, non-profit purposes can be sent to christian.mueller@usb.ch. Data availability will begin 6 months after publication. The anticipated timeframe for response is around 4 weeks. A data dictionary, the study protocol, and the statistical analysis plan can be made available. All requests will be reviewed by the corresponding author, the ethics committees, and University Hospital Basel to evaluate the merit of the research proposed, the availability of the data, the intended use of the data, and the presence of conflicts of interest. A signed data access agreement with the sponsor is required before data sharing.

Locations

RO (1); FI (1); US (1); GR (1); AU (1); ES (4); CH (4); GB (2); KR (1); IT (3)