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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
64,374
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.
High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.
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
...and 10 more locations
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
Time frame: 30 days
Time from ED presentation to ED discharge or transfer
Length of stay in the ED measured in hours
Time frame: 30 days
Proportion of patients managed as outpatients
Number of patients who stay in hospital for index event less than 24 hours
Time frame: 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
Time frame: 30 days
All-cause mortality at 30 days in all patients
Number of deceased patients within 30 days after index presentation
Time frame: 30 days
All-cause mortality at 365 days in all patients
Number of deceased patients within 365 days after index presentation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days
Treatment costs in the ED
Costs of procedures performed in the ED will be calculated according to national remuneration systems
Time frame: 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
Time frame: 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
Time frame: 80 minutes
Effectiveness of rule-in
Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1)
Time frame: 30 days
Effectiveness of rule-out
Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease
Time frame: 30 days
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