NSTEMI - Non-ST Segment Elevation MI Clinical Trial
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
NCT number | NCT03489603 |
Other study ID # | TROCAR 2017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2017 |
Est. completion date | June 15, 2019 |
Verified date | February 2021 |
Source | Istituto Superiore di Sanità |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2913 |
Est. completion date | June 15, 2019 |
Est. primary completion date | July 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Superiore di Sanità | Roma |
Lead Sponsor | Collaborator |
---|---|
Marco Marchetti | 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 |
Italy,
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Apple FS, Ler R, Murakami MM. Determination of 19 cardiac troponin I and T assay 99th percentile values from a common presumably healthy population. Clin Chem. 2012 Nov;58(11):1574-81. doi: 10.1373/clinchem.2012.192716. Epub 2012 Sep 14. — View Citation
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Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. [2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)]. G Ital Cardiol (Rome). 2016 Oct;17(10):831-872. doi: 10.1714/2464.25804. Italian. — View Citation
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Shah AS, Anand A, Sandoval Y, Lee KK, Smith SW, Adamson PD, Chapman AR, Langdon T, Sandeman D, Vaswani A, Strachan FE, Ferry A, Stirzaker AG, Reid A, Gray AJ, Collinson PO, McAllister DA, Apple FS, Newby DE, Mills NL; High-STEACS investigators. High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet. 2015 Dec 19;386(10012):2481-8. doi: 10.1016/S0140-6736(15)00391-8. Epub 2015 Oct 8. — View Citation
Shah AS, Griffiths M, Lee KK, McAllister DA, Hunter AL, Ferry AV, Cruikshank A, Reid A, Stoddart M, Strachan F, Walker S, Collinson PO, Apple FS, Gray AJ, Fox KA, Newby DE, Mills NL. High sensitivity cardiac troponin and the under-diagnosis of myocardial infarction in women: prospective cohort study. BMJ. 2015 Jan 21;350:g7873. doi: 10.1136/bmj.g7873. Erratum in: BMJ. 2015;350:h626. Erratum in: BMJ. 2016 Sep 06;354:i4840. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to diagnosis in the emergency department | Time from admission at the emergency department and diagnosis or exclusion of NSTEMI | 1-3-6 hours | |
Secondary | Number of ruled-in and ruled-out patients | 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 | |
Secondary | Number of tests performed | Number of high-sensitivity cardiac troponin tests performed | 1-3-6 hours | |
Secondary | Number of patients diagnosed with a Major Adverse Clinical Event | number of patients with myocardial infarction, stroke, or unplanned revascularization | 30 days after the first assessment | |
Secondary | 30-day mortality | Death rate 30 days after admission to the emergency department | 30 days following admission |
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