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NCT Number: NCT03489603

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

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.

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Key information

Conditions

NSTEMI - Non-ST Segment Elevation MI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Superiore di Sanità

Roma, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number of tests performed

    Time frame: 1-3-6 hours

    Number of high-sensitivity cardiac troponin tests performed

  3. 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

  4. 30-day mortality

    Time frame: 30 days following admission

    Death rate 30 days after admission to the emergency department

Sponsors and collaborators

Lead sponsor

Marco Marchetti

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 5, 2018
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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