CClinicalTrials.gg
Active, not recruitingNCT05649384PRESC1SE-MIUpdated Sep 17, 2026

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

An interventional study of European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm and European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm in Acute Chest Pain and NSTEMI - Non-ST Segment Elevation MI, sponsored by University Hospital, Basel, Switzerland. Active, not recruiting at 20 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Dec 2020, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
64,374
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • 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
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In context

Non-ST Elevated Myocardial Infarction

147 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 41 are open to participants now.

This study's planned enrollment of 64,374 is above the median of 300 across 82 interventional studies indexed under Non-ST Elevated Myocardial Infarction.

Browse Non-ST Elevated Myocardial Infarction studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Terminal kidney failure requiring dialysis
  • Cardiac arrest
  • Cardiogenic shock
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64,374 participants (estimated)

Study arms

  • Experimental
    0/1-hour algorithm

    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

  • Active comparator
    0/3-hour algorithm

    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

  • Diagnostic testEuropean Society of Cardiology hs-cTnT/I 0 h/1 h algorithm

    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

  • Diagnostic testEuropean Society of Cardiology hs-cTnT/I 0 h/3 h algorithm

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. Time from ED presentation to ED discharge or transfer

    Length of stay in the ED measured in hours

    Time frame: 30 days

Secondary outcomes

  1. Proportion of patients managed as outpatients

    Number of patients who stay in hospital for index event less than 24 hours

    Time frame: 24 hours

  2. Readmission for suspected AMI within 30 days after index presentation

    Number of patients who stay in hospital for a new suspected AMI more than 24 hours within 30 days of index presentation

    Time frame: 30 days

  3. All-cause mortality at 30 days in all patients

    Number of deceased patients within 30 days after index presentation

    Time frame: 30 days

  4. All-cause mortality at 365 days in all patients

    Number of deceased patients within 365 days after index presentation

    Time frame: 365 days

  5. New AMI (type1) at 30 days in all patients

    Number of newly diagnosed AMI (type 1) in all patients within 30 days of index presentation

    Time frame: 30 days

  6. New AMI (type 1) at 365 days in all patients

    Number of newly diagnosed AMI (type 1) in all patients within 365 days of index presentation

    Time frame: 365 days

  7. Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation

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

    Time frame: 365 days

  8. Satisfaction of patients with their evaluation in the ED

    Satisfaction will be measured on a numerical/visual analogue scale from 0-100%, the higher the score, the greater the satisfaction

    Time frame: 30 days

  9. Treatment costs in the ED

    Costs of procedures performed in the ED will be calculated according to national remuneration systems

    Time frame: 365 days

  10. Length of stay in the ED

    Length of stay from admission to the ED to discharge or transfer will be calculated according to national remuneration systems

    Time frame: 30 days

  11. Feasibility of the 0/1-hour algorithm

    Feasibility defined as the percentage of patients in whom the "1h" blood draw is performed within 1h +/- 20 minutes from the "0h" blood draw

    Time frame: 80 minutes

  12. Effectiveness of rule-in

    Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)

    Time frame: 30 days

  13. Effectiveness of rule-out

    Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease

    Time frame: 30 days

07

Study locations

20 sites
  • Baylor St. Luke's Medical Center
    Houston, Texas 77030, United States
  • St Andrew's War Memorial Hospital Brisbane
    Brisbane, Australia
  • Vienna General Hospital (AKH Wien)
    Vienna, Austria
  • University Central Hospital Helsinki
    Helsinki, Finland
  • Attikon General Hospital Athens
    Athens, Greece
  • Careggi University Hospital Florence
    Florence, Italy
  • Azienda Ospedaliera San Giovanni Addolorata
    Roma, Italy
  • Hospital Città della Salute e della Scienza di Torino
    Torino, Italy
  • Emergency Institute for Cardiovascular Diseases C.C. Iliescu
    Bucharest, Romania
  • Konkuk University Medical Center
    Seoul, South Korea
  • Hospital Clinic Barcelona
    Barcelona, Spain
  • University Hospital October 12 Madrid
    Madrid, Spain
  • University Hospital Ramon y Cajal
    Madrid, Spain
  • Hospital Clínico Universitario Valencia
    Valencia, Spain
  • Kantonsspital Aarau
    Aarau, Switzerland
  • St. Claraspital
    Basel, Switzerland
  • Kantonsspital Luzern
    Lucerne, Switzerland
  • University Hospital Zurich
    Zurich, Switzerland
  • Royal London Hospital
    London, United Kingdom
  • Royal Cornwall Hospitals Treliske
    Truro, United Kingdom
08

References and documents

Publications

  • 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. PubMed 42667934 ↗
  • 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. PubMed 41177204 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in the article will be available for academic, non-profit purposes. A data dictionary, the study protocol, and the statistical analysis plan may also be made available.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05649384
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Dec 14, 2022
Start date
Dec 1, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Christian Müller, MD Prof.
principal investigator · University Hospital, Basel, Switzerland
Jasper Boeddinghaus, MD
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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