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Active Not RecruitingNCT05649384

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

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)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
64,374 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEuropean Society of Cardiology hs-cTnT/I 0 h/1 h algorithmHigh-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
DIAGNOSTIC_TESTEuropean Society of Cardiology hs-cTnT/I 0 h/3 h algorithmHigh-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.

Timeline

Start date
2020-12-01
Primary completion
2027-12-31
Completion
2028-05-31
First posted
2022-12-14
Last updated
2026-01-27

Locations

20 sites across 11 countries: United States, Australia, Austria, Finland, Greece, Italy, Romania, South Korea, Spain, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT05649384. Inclusion in this directory is not an endorsement.