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

NCT ID: NCT05649384

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

European 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.

Intervention Type: DIAGNOSTIC_TEST

European 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

0/1-hour algorithm; 0/3-hour algorithm

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Müller, MD Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Jasper Boeddinghaus, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Baylor St. Luke's Medical Center

Houston, Texas, 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

Countries

United States; Australia; Austria; Finland; Greece; Italy; Romania; South Korea; Spain; Switzerland; United Kingdom

Other Identifiers

2019-02269

Identifier Type: -

Identifier Source: org_study_id