Clinical trial NCT05649384: Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 64374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Composite of all-cause mortality or new AMI (type 1) occurring within 30 days of index presentation
timeFrame: 30 days
measure: Time from ED presentation to ED discharge or transfer
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of patients managed as outpatients
timeFrame: 24 hours
measure: Readmission for suspected AMI within 30 days after index presentation
timeFrame: 30 days
measure: All-cause mortality at 30 days in all patients
timeFrame: 30 days
measure: All-cause mortality at 365 days in all patients
timeFrame: 365 days
measure: New AMI (type1) at 30 days in all patients
timeFrame: 30 days
measure: New AMI (type 1) at 365 days in all patients
timeFrame: 365 days
measure: Composite of all-cause mortality or new AMI (type 1) at 365 days after index presentation
timeFrame: 365 days
measure: Satisfaction of patients with their evaluation in the ED
timeFrame: 30 days
measure: Treatment costs in the ED
timeFrame: 365 days
measure: Length of stay in the ED
timeFrame: 30 days
measure: Feasibility of the 0/1-hour algorithm
timeFrame: 80 minutes
measure: Effectiveness of rule-in
timeFrame: 30 days
measure: Effectiveness of rule-out
timeFrame: 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Brisbane
country: Australia
facility: St Andrew's War Memorial Hospital Brisbane
city: Wien
country: Austria
facility: Vienna General Hospital (AKH Wien)
city: Helsinki
country: Finland
facility: University Central Hospital Helsinki
city: Athens
country: Greece
facility: Attikon General Hospital Athens
city: Florence
country: Italy
facility: Careggi University Hospital Florence
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
city: Torino
country: Italy
facility: Hospital Città della Salute e della Scienza di Torino
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Bucharest
country: Romania
facility: Emergency Institute for Cardiovascular Diseases C.C. Iliescu
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: University Hospital October 12 Madrid
city: Madrid
country: Spain
facility: University Hospital Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Clínico Universitario Valencia
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: St. Claraspital
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: London
country: United Kingdom
facility: Royal London Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals Treliske
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian Müller, MD Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Jasper Boeddinghaus, MD
role: PRINCIPAL_INVESTIGATOR
References: