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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

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ClinicalTrials.gov Identifier: NCT03489603
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Sanitaria Locale ASL 6, Livorno
Azienda Ospedaliera 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
Information provided by (Responsible Party):
Marco Marchetti, 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.


Condition or disease
NSTEMI - Non-ST Segment Elevation MI

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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending the Emergency Department with chest pain
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489603


Contacts
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Contact: Marco Marchetti, MD 49906710 ext 06 marco.marchetti@iss.it
Contact: Laura Camoni, MD 49904131 ext 06 laura.camoni@iss.it

Locations
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Italy
Istituto Superiore di Sanità Recruiting
Roma, Italy, 00161
Contact: Marco Marchetti    49906710 ext 06    marco.marchetti@iss.it   
Contact: Laura Camoni    49904131 ext 06    laura.camoni@iss.it   
Sponsors and Collaborators
Marco Marchetti
Azienda Ospedaliero Universitaria Maggiore della Carita
Azienda Sanitaria Locale ASL 6, Livorno
Azienda Ospedaliera 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
Investigators
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Principal Investigator: Marco Marchetti, MD Istituto Superiore di Sanità
  Study Documents (Full-Text)

Documents provided by Marco Marchetti, Istituto Superiore di Sanità:
Statistical Analysis Plan  [PDF] April 13, 2017
Study Protocol  [PDF] April 13, 2017


Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons, Thygesen K, Alpert JS, White HD; Biomarker Subcommittee, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee, Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee, Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG), Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers, Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5.

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Responsible Party: Marco Marchetti, Director of the National Health Technology Assessment Centre, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT03489603     History of Changes
Other Study ID Numbers: TROCAR 2017
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marco Marchetti, Istituto Superiore di Sanità:
Troponin
Additional relevant MeSH terms:
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Non-ST Elevated Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases