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

February 25, 2021 updated by: Marco Marchetti

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2913

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Istituto Superiore di Sanità

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending the Emergency Department with chest pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3-6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3-6 hours
Number of tests performed
Time Frame: 1-3-6 hours
Number of high-sensitivity cardiac troponin tests performed
1-3-6 hours
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 days after the first assessment
30-day mortality
Time Frame: 30 days following admission
Death rate 30 days after admission to the emergency department
30 days following admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marco Marchetti

Collaborators

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

Investigators

  • Principal Investigator: Marco Marchetti, MD, Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 11, 2017

Primary Completion (ACTUAL)

July 11, 2018

Study Completion (ACTUAL)

June 15, 2019

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROCAR 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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