Valutazione Clinica e Farmacoeconomica Delle Metodiche di Dosaggio Per la TROponina CARdiaca Per la Diagnosi di NSTEMI Nel Setting Della Pratica Clinica Della Medicina di Pronto Soccorso Nel Territorio Nazionale
Conditions: NSTEMI - Non-ST Segment Elevation MI
Sponsor: Marco Marchetti

Synopsis _TROCAR 2017_vers.13/04/2017 
 
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OBSERVATIONAL STUDY 
Clinical and Economic Outcomes of hs-cTns for diagnosis of NSTEMI in 
Patients With Chest Pain in EDs in Italy-An Observational Study - 
TROCAR 2017 
 
 
 
 
 
 
No Profit Study: TROCAR 2017 
 
 
 
 
 
Promoter 
National Institute of Health - Istituto Superiore di Sanità (ISS) 
National Centre for Health Technology Assessment - Centro Nazionale per l’Health 
Technology Assessment (HTA) 
Viale Regina Elena 299 
00161 Roma 
 
 
 
 
 
Version 13_April_2017 
 

Synopsis _TROCAR 2017_vers.13/04/2017 
 
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SUMMARY 
 
This multicenter observational study is a clinical, organizational and economic evaluation of 
the different quantitative assays of high-sensitivity cardiac troponin in patients with 
suspected acute myocardial infarction and non-ST-elevation ECG (NSTEMI) at admission 
at 12 Italian Emergency Departments. 
 
 
This document provides a synopsis of the Study Protocol (original in Italian) 
 
SYNOPSIS 
 
Title 
Clinical and Economic Outcomes of hs-cTns for diagnosis 
of NSTEMI in Patients With Chest Pain in EDs in Italy-An 
Observational Study  TROCAR 2017 
Promoter 
 
National Institute of Health 
National Health Technology Assessment Centre 
Type of study 
No profit with in vitro diagnostic medical devices routinely 
employed in clinical practice  
Clinical phase 
Post marketing 
 
Background 
Myocardial infarction is one of the leading causes of death and 
disability worldwide. In addition to standard diagnostic methods, 
it has been shown that high-sensitivity cardiac troponin assays 
allow greater sensitivity in the diagnosis of myocardial infarction 
and assume a central role for both exclusion ("rule out") and 
confirmation ("rule in") of acute myocardial infarction, while  
allowing to reduce the time interval between Emergency 
Department admission and presumptive diagnosis. 
Considering the relevance of this topic, we propose to conduct 
an observational study in real world clinical practice settings at 
Emergency Departments, aiming to evaluate clinical and 
economic aspects deriving from the use of the different 
quantitative assays of high-sensitivity cardiac troponin currently 
available in patients with suspected acute myocardial infarction 
and non-ST-elevation ECG (No ST elevation myocardial 
infarction - NSTEMI) at admission, including time of diagnosis 
and number of laboratory and imaging tests performed. 
 
Study design 
Observational 
 
Objective 
Clinical, organizational and economic evaluation of the different 
quantitative assays of high-sensitivity cardiac troponin in patients 
with suspected acute myocardial infarction and non-ST-elevation 
ECG (NSTEMI) at admission at the Emergency Department 
 

Synopsis _TROCAR 2017_vers.13/04/2017 
 
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Primary Endpoint  
Time to diagnosis at the Emergency Department  
Secondary Endpoints  
% rule in patients (NSTEMI diagnosis) 
% rule out patients (exclusion of NSTEMI) 
% patients dead 30 days after Emergency Department admission 
% patients with  myocardial infarction 30 days after Emergency 
Department admission 
% patients with major adverse events 30 days after ED 
admission 
Pharmacoeconomic 
endpoint 
Number and cost of laboratory and imaging tests performed at 
the Emergency Department 
 
Evaluation 
of 
effectiveness 
Outcome measures: time of diagnosis, death or myocardial 
infarction 30 days after Emergency Department admission. 
 
Sensitivity and Negative Predictive Value of myocardial Infarction 
(“rule out”) with different quantitative assays of high-sensitivity 
cardiac troponin, according to the standard operating protocols 
of the participating Centers. 
Sensitivity and Negative Predictive Value will be evaluated in 
relation to: 
a) limit of detection of the used assay 
b) 99th percentile of the reference healthy population  
 
Evaluation of 30-day prognosis 
 
Evaluation of costs of any further examinations after the first  
 
Safety evaluation 
N.A. (already provided in the Hospital) 
Expected 
number 
of 
patients   
500 patients for each Centre 
Type of patients 
 
Patients with suspected acute myocardial infarction and non-ST-
elevation ECG (NSTEMI) at admission at the Emergency 
Department 
 
Type and number of 
centres 
12 Emergency Departments 
Enrollment 
Consecutive  
Number of examinations Patients will be examined at enrollment in the Emergency 
Departments, and after 30-days  
 
Inclusion and exclusion 
criteria 
Inclusion criteria 
 
 both sexes 
 ≥18 years old 
 Patients with chest pain 
 At least one high-sensitivity cardiac troponin test 
performed 
 Written informed consent 
 

Synopsis _TROCAR 2017_vers.13/04/2017 
 
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Exclusion criteria 
 
Refusal to provide informed consent 
 
Elevation of ST segment in the ECG 
 
Pregnancy or breastfeeding 
 
Any other clinical conditions not compatible with 
participation at the study 
 
Used in-vitro medical 
device 
 
Different quantitative assays of high-sensitivity cardiac troponin 
currently available and used in the Emergency Department 
Length of study 
January 2018 - July 2018 
 
 

Synopsis _TROCAR 2017_vers.13/04/2017 
 
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References 
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Heart J 2016; 37: 267-315.                                                                                                                       
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Biomarkers. Analytical Characteristics of High-Sensitivity Cardiac Troponin Assays Clin 
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4. Apple FS, Lee R, Murakami MM. Determination of 19 cardiac troponin I and T assay 99th 
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