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

Completed

• Conditions: NSTEMI - Non-ST Segment Elevation MI

• Registration Number: NCT03489603
• Lead Sponsor: Marco Marchetti

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.

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Primary Completion: 2018-07-11
• Study Completion: 2019-06-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2913

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Number of tests performed	1-3-6 hours	Number of high-sensitivity cardiac troponin tests performed

Trial Locations

Locations (1)

Istituto Superiore di Sanità; 🇮🇹 Roma, Italy