NCT03489603

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,913 (actual)
• Sponsor: Marco Marchetti · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSTEMI - Non-ST Segment Elevation MI

Timeline

• Start date: 2017-10-11
• Primary completion: 2018-07-11
• Completion: 2019-06-15
• First posted: 2018-04-05
• Last updated: 2021-02-26

Locations

1 site across 1 country: Italy