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
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|ClinicalTrials.gov Identifier: NCT03489603|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : February 27, 2019
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.
|Condition or disease|
|NSTEMI - Non-ST Segment Elevation MI|
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|
|Estimated Enrollment :||3000 participants|
|Official Title:||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|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
- Time to diagnosis in the emergency department [ Time Frame: 1-3-6 hours ]Time from admission at the emergency department and diagnosis or exclusion of NSTEMI
- Number of ruled-in and ruled-out patients [ Time Frame: 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 [ Time Frame: 1-3-6 hours ]Number of high-sensitivity cardiac troponin tests performed
- Number of patients diagnosed with a Major Adverse Clinical Event [ Time Frame: 30 days after the first assessment ]number of patients with myocardial infarction, stroke, or unplanned revascularization
- 30-day mortality [ Time Frame: 30 days following admission ]Death rate 30 days after admission to the emergency department
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489603
|Contact: Marco Marchetti, MD||49906710 ext email@example.com|
|Contact: Laura Camoni, MD||49904131 ext firstname.lastname@example.org|
|Istituto Superiore di Sanità||Recruiting|
|Roma, Italy, 00161|
|Contact: Marco Marchetti 49906710 ext 06 email@example.com|
|Contact: Laura Camoni 49904131 ext 06 firstname.lastname@example.org|
|Principal Investigator:||Marco Marchetti, MD||Istituto Superiore di Sanità|