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

Study Overview
=================
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.

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)

Conditions
-----------------
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 0/1-hour algorithm<br>High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department. | Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/1 h algorithm<br>* High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 1 hour later in the emergency department.<br>* Other names: 0/1-hour algorithm;|
| 0/3-hour algorithm<br>High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department. | Diagnostic Test: European Society of Cardiology hs-cTnT/I 0 h/3 h algorithm<br>* High-sensitivity cardiac troponin (hs-cTn) blood tests are performed at admission (0 h) and 3 hours later in the emergency department.<br>* Other names: 0/3-hour algorithm;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 
| Time from ED presentation to ED discharge or transfer | Length of stay in the ED measured in hours | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients managed as outpatients | Number of patients who stay in hospital for index event less than 24 hours | 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 | 30 days | 
| All-cause mortality at 30 days in all patients | Number of deceased patients within 30 days after index presentation | 30 days | 
| All-cause mortality at 365 days in all patients | Number of deceased patients within 365 days after index presentation | 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 | 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 | 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 | 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 | 30 days | 
| Treatment costs in the ED | Costs of procedures performed in the ED will be calculated according to national remuneration systems | 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 | 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 | 80 minutes | 
| Effectiveness of rule-in | Effectiveness defined as the time from presentation to coronary angiography in patients ultimately diagnosed with AMI (type 1) | 30 days | 
| Effectiveness of rule-out | Effectiveness defined as time from presentation to discharge in patients ultimately diagnosed with non-cardiac disease | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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