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

University Hospital Basel

Status: Active, not recruiting

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

Treatments: Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm; Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT05649384

2019-02269

Details and patient eligibility

About

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.

Enrollment: 64,374 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64,374 participants in 2 patient groups

0/1-hour algorithm

Experimental group

Description:

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

Treatment:

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

0/3-hour algorithm

Active Comparator group

Description:

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

Treatment:

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