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
Lead Sponsor: Marco Marchetti
Azienda Ospedaliero Universitaria Maggiore della Carita
|Source||Istituto Superiore di Sanità|
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.
|Start Date||January 18, 2018|
|Completion Date||August 2019|
|Primary Completion Date||August 2019|
Sampling Method: Non-Probability Sample
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.
- Patients with chest pain
- Performing at least one cardiac troponin determination test
- Written informed consent
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Last Name: Marco Marchetti, MD
Phone Ext.: 06
Email: [email protected]
Investigator Affiliation: Istituto Superiore di Sanità
Investigator Full Name: Marco Marchetti
Investigator Title: Director of the National Health Technology Assessment Centre
|Has Expanded Access||No|
|Study Design Info||
Observational Model: Other
Time Perspective: Prospective