Clinical and Economic Outcomes of High Sensitivity Troponin for no ST Elevation Myocardial Infarction in Patients With Chest Pain in Emergency Departments in Italy-An Observational Study

Study Overview
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Brief Summary
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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 ER 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 (NSTEMI) on the admission, including time of diagnosis and number of laboratory and imaging tests performed.

Detailed Description
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Observational, prospective, real-world clinical practice, multicentric study, conducted at 12 Emergency Departments in Italy. Patients with suspected non-ST-elevation myocardial infarction (NSTEMI) who have undergone at least one high-sensitivity cardiac troponin test will be included. Patients will be enrolled in the study after verification of selection criteria. Enrollment is consecutive; each Center will suspend enrollment when it has reached the expected number of patients. An electronic data collection form (eCRF) will be used to automatically generate an enrollment number to identify each patient. Given the observational nature of the study, high-sensitivity cardiac troponin assays will be used according to current clinical practice. Patients will be examined in the ED, and on a 30-day follow-up.

Official Title
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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
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NSTEMI - Non-ST Segment Elevation MI

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chest pain Performing at least one cardiac troponin determination test Written informed consent Exclusion Criteria: Refusal to provide informed consent Elevation of the ST segment to the ECG Pregnancy or breastfeeding Any other clinical condition not judged by the investigator compatible with participation in the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to diagnosis in the emergency department | Time from admission at the emergency department and diagnosis or exclusion of NSTEMI | 1-3-6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ruled-in and ruled-out patients | Number of patients diagnosed with NSTEMI and hospitalized, and number of patients discharged from the emergency room after exclusion of NSTEMI | 1-3-6 hours | 
| Number of tests performed | Number of high-sensitivity cardiac troponin tests performed | 1-3-6 hours | 
| Number of patients diagnosed with a Major Adverse Clinical Event | number of patients with myocardial infarction, stroke, or unplanned revascularization | 30 days after the first assessment | 
| 30-day mortality | Death rate 30 days after admission to the emergency department | 30 days following admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Troponin