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

Sponsors

Lead Sponsor: Marco Marchetti

Collaborator: Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Sanitaria Locale ASL 6, Livorno
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ospedale Civile - Padova
S. Andrea Hospital
Azienda Policlinico Umberto I
San Carlo Public Hospital, Potenza, Italy
Azienda Ospedaliero-Universitaria Consorziale
Policlinico Universitario, Catania
Azienda Ospedaliera Sant'Anna
Ospedale di Cattinara - Azienda Universitaria Integrata -Trieste
Abbott
Informapro Srl

Source Istituto Superiore di Sanità
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.

Overall Status Recruiting
Start Date January 18, 2018
Completion Date August 2019
Primary Completion Date August 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Time to diagnosis in the emergency department 1-3-6 hours
Secondary Outcome
Measure Time Frame
Number of ruled-in and ruled-out patients 1-3-6 hours
Number of tests performed 1-3-6 hours
Number of patients diagnosed with a Major Adverse Clinical Event 30 days after the first assessment
30-day mortality 30 days following admission
Enrollment 3000
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marco Marchetti, MD Principal Investigator Istituto Superiore di Sanità
Overall Contact

Last Name: Marco Marchetti, MD

Phone: 49906710

Phone Ext.: 06

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Istituto Superiore di Sanità Marco Marchetti 49906710 06 [email protected]
Location Countries

Italy

Verification Date

February 2019

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Istituto Superiore di Sanità

Investigator Full Name: Marco Marchetti

Investigator Title: Director of the National Health Technology Assessment Centre

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov