Acute Chest PainPRESC1SE-MINCT05649384
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
A study testing 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 people with Acute Chest Pain and NSTEMI - Non-ST Segment Elevation MI, run by University Hospital, Basel, Switzerland at 20 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64,374 participants
- Where
- 20 sitesin 11 countries
- Study dates
- 1 Dec 2020to 31 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above
- Presentation with acute non-traumatic acute chest pain to the emergency department
- Suspicion of acute myocardial infarction
Who cannot join
- Terminal kidney failure requiring dialysis
- Cardiac arrest
- Cardiogenic shock
Trial locations and contacts
20 sites in 11 countries.
20 sites in 11 countries
Spain4 sites
Hospital Clinic Barcelona
Barcelona
University Hospital October 12 Madrid
Madrid
University Hospital Ramon y Cajal
Madrid
Hospital Clínico Universitario Valencia
Valencia
Switzerland4 sites
Kantonsspital Aarau
Aarau
St. Claraspital
Basel
Kantonsspital Luzern
Lucerne
University Hospital Zurich
Zurich
Italy3 sites
Careggi University Hospital Florence
Florence
Azienda Ospedaliera San Giovanni Addolorata
Roma
Hospital Città della Salute e della Scienza di Torino
Torino
United Kingdom2 sites
Royal London Hospital
London
Royal Cornwall Hospitals Treliske
Truro
United States1 site
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Romania1 site
Emergency Institute for Cardiovascular Diseases C.C. Iliescu
Bucharest
About this study
Official title: PRospective Evaluation of the European Society of Cardiology 0/1-hour Algorithm's Safety and Efficacy for Triage of Patients With Suspected Myocardial Infarction (PRESC1SE-MI)
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.
- Being tested
- European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm, European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm
- 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
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Emergencies, Chest Pain, Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Society of Cardiology hs-cTnT/I 0 h/1 h algorithmDiagnostic test
Also called 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.
European Society of Cardiology hs-cTnT/I 0 h/3 h algorithmDiagnostic test
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Time from ED presentation to ED discharge or transfer
Length of stay in the ED measured in hours
Measured: 30 days
Secondary outcomes (13)
Proportion of patients managed as outpatients
Number of patients who stay in hospital for index event less than 24 hours
Measured: 24 hours
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
Measured: 30 days
All-cause mortality at 30 days in all patients
Number of deceased patients within 30 days after index presentation
Measured: 30 days
All-cause mortality at 365 days in all patients
Number of deceased patients within 365 days after index presentation
Measured: 365 days
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
Measured: 30 days
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
Measured: 365 days
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
Measured: 365 days
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
Measured: 30 days
Treatment costs in the ED
Costs of procedures performed in the ED will be calculated according to national remuneration systems
Measured: 365 days
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
Measured: 30 days
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
Measured: 80 minutes
Effectiveness of rule-in
Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)
Measured: 30 days
Effectiveness of rule-out
Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 64,374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Müller, MD Prof., Principal investigator, University Hospital, Basel, SwitzerlandJasper Boeddinghaus, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649384
- Sponsor's protocol ID
- 2019-02269
- Other IDs
- 2019
- Acronym
- PRESC1SE-MI
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 42667934Boeddinghaus 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