Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT03489603
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Marco Marchetti
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: