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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,913
Istituto Superiore di Sanità
Roma, Italy
Time to diagnosis in the emergency department
Time from admission at the emergency department and diagnosis or exclusion of NSTEMI
Time frame: 1-3-6 hours
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
Time frame: 1-3-6 hours
Number of tests performed
Number of high-sensitivity cardiac troponin tests performed
Time frame: 1-3-6 hours
Number of patients diagnosed with a Major Adverse Clinical Event
number of patients with myocardial infarction, stroke, or unplanned revascularization
Time frame: 30 days after the first assessment
30-day mortality
Death rate 30 days after admission to the emergency department
Time frame: 30 days following admission
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