NSTEMI - Non-ST Segment Elevation MI
Conditions
Keywords
Troponin
Brief summary
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
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.
Interventions
None listed
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Sanitaria Locale ASL 6, Livorno
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ospedale Civile - Padova
S. Andrea Hospital
Azienda Policlinico Umberto I
San Carlo Public Hospital, Potenza, Italy
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Policlinico Universitario, Catania
Azienda Ospedaliera Sant'Anna
Ospedale di Cattinara - Azienda Universitaria Integrata -Trieste
Abbott
Informapro Srl
Marco Marchetti
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to diagnosis in the emergency department | 1-3-6 hours | Time from admission at the emergency department and diagnosis or exclusion of NSTEMI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ruled-in and ruled-out patients | 1-3-6 hours | Number of patients diagnosed with NSTEMI and hospitalized, and number of patients discharged from the emergency room after exclusion of NSTEMI |
| Number of tests performed | 1-3-6 hours | Number of high-sensitivity cardiac troponin tests performed |
| Number of patients diagnosed with a Major Adverse Clinical Event | 30 days after the first assessment | number of patients with myocardial infarction, stroke, or unplanned revascularization |
| 30-day mortality | 30 days following admission | Death rate 30 days after admission to the emergency department |
Countries
Italy
Outcome results
None listed