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European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications

BACKGROUND: Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European...

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Autores principales: Biancari, Fausto, Ruggieri, Vito G, Perrotti, Andrea, Svenarud, Peter, Dalén, Magnus, Onorati, Francesco, Faggian, Giuseppe, Santarpino, Giuseppe, Maselli, Daniele, Dominici, Carmelo, Nardella, Saverio, Musumeci, Francesco, Gherli, Riccardo, Mariscalco, Giovanni, Masala, Nicola, Rubino, Antonino S., Mignosa, Carmelo, De Feo, Marisa, Corte, Alessandro Della, Bancone, Ciro, Chocron, Sidney, Gatti, Giuseppe, Gherli, Tiziano, Kinnunen, Eeva-Maija, Juvonen, Tatu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485338/
https://www.ncbi.nlm.nih.gov/pubmed/26123033
http://dx.doi.org/10.1186/s13019-015-0292-z
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author Biancari, Fausto
Ruggieri, Vito G
Perrotti, Andrea
Svenarud, Peter
Dalén, Magnus
Onorati, Francesco
Faggian, Giuseppe
Santarpino, Giuseppe
Maselli, Daniele
Dominici, Carmelo
Nardella, Saverio
Musumeci, Francesco
Gherli, Riccardo
Mariscalco, Giovanni
Masala, Nicola
Rubino, Antonino S.
Mignosa, Carmelo
De Feo, Marisa
Corte, Alessandro Della
Bancone, Ciro
Chocron, Sidney
Gatti, Giuseppe
Gherli, Tiziano
Kinnunen, Eeva-Maija
Juvonen, Tatu
author_facet Biancari, Fausto
Ruggieri, Vito G
Perrotti, Andrea
Svenarud, Peter
Dalén, Magnus
Onorati, Francesco
Faggian, Giuseppe
Santarpino, Giuseppe
Maselli, Daniele
Dominici, Carmelo
Nardella, Saverio
Musumeci, Francesco
Gherli, Riccardo
Mariscalco, Giovanni
Masala, Nicola
Rubino, Antonino S.
Mignosa, Carmelo
De Feo, Marisa
Corte, Alessandro Della
Bancone, Ciro
Chocron, Sidney
Gatti, Giuseppe
Gherli, Tiziano
Kinnunen, Eeva-Maija
Juvonen, Tatu
author_sort Biancari, Fausto
collection PubMed
description BACKGROUND: Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry. DESIGN: The E-CABG registry is a multicenter study and its data are prospectively collected from 13 centers of cardiac surgery in university and community hospitals located in six European countries (England, Italy, Finland, France, Germany, Sweden). Data on major and minor immediate postoperative adverse events will be collected. Data on late all-cause mortality, stroke, myocardial infarction and repeat revascularization will be collected during a 10-year follow-up period. These investigators provided a score from 0 to 10 for any major postoperative adverse events and their rounded medians were used to stratify the severity of these complications in four grades. The sum of these scores for each complication/intervention occurring after coronary artery bypass grafting will be used as an additive score for further stratification of the prognostic importance of these events. DISCUSSION: The E-CABG registry is expected to provide valuable data for identification of risk factors and treatment strategies associated with suboptimal outcome. These information may improve the safety and durability of coronary artery bypass grafting. The proposed classification of postoperative complications may become a valuable research tool to stratify the impact of such complications on the outcome of these patients and evaluate the burden of resources needed for their treatment. CLINICAL TRIALS NUMBER: NCT02319083
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spelling pubmed-44853382015-07-01 European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications Biancari, Fausto Ruggieri, Vito G Perrotti, Andrea Svenarud, Peter Dalén, Magnus Onorati, Francesco Faggian, Giuseppe Santarpino, Giuseppe Maselli, Daniele Dominici, Carmelo Nardella, Saverio Musumeci, Francesco Gherli, Riccardo Mariscalco, Giovanni Masala, Nicola Rubino, Antonino S. Mignosa, Carmelo De Feo, Marisa Corte, Alessandro Della Bancone, Ciro Chocron, Sidney Gatti, Giuseppe Gherli, Tiziano Kinnunen, Eeva-Maija Juvonen, Tatu J Cardiothorac Surg Study Protocol BACKGROUND: Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry. DESIGN: The E-CABG registry is a multicenter study and its data are prospectively collected from 13 centers of cardiac surgery in university and community hospitals located in six European countries (England, Italy, Finland, France, Germany, Sweden). Data on major and minor immediate postoperative adverse events will be collected. Data on late all-cause mortality, stroke, myocardial infarction and repeat revascularization will be collected during a 10-year follow-up period. These investigators provided a score from 0 to 10 for any major postoperative adverse events and their rounded medians were used to stratify the severity of these complications in four grades. The sum of these scores for each complication/intervention occurring after coronary artery bypass grafting will be used as an additive score for further stratification of the prognostic importance of these events. DISCUSSION: The E-CABG registry is expected to provide valuable data for identification of risk factors and treatment strategies associated with suboptimal outcome. These information may improve the safety and durability of coronary artery bypass grafting. The proposed classification of postoperative complications may become a valuable research tool to stratify the impact of such complications on the outcome of these patients and evaluate the burden of resources needed for their treatment. CLINICAL TRIALS NUMBER: NCT02319083 BioMed Central 2015-06-30 /pmc/articles/PMC4485338/ /pubmed/26123033 http://dx.doi.org/10.1186/s13019-015-0292-z Text en © Biancari et al. 2015 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Biancari, Fausto
Ruggieri, Vito G
Perrotti, Andrea
Svenarud, Peter
Dalén, Magnus
Onorati, Francesco
Faggian, Giuseppe
Santarpino, Giuseppe
Maselli, Daniele
Dominici, Carmelo
Nardella, Saverio
Musumeci, Francesco
Gherli, Riccardo
Mariscalco, Giovanni
Masala, Nicola
Rubino, Antonino S.
Mignosa, Carmelo
De Feo, Marisa
Corte, Alessandro Della
Bancone, Ciro
Chocron, Sidney
Gatti, Giuseppe
Gherli, Tiziano
Kinnunen, Eeva-Maija
Juvonen, Tatu
European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title_full European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title_fullStr European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title_full_unstemmed European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title_short European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications
title_sort european multicenter study on coronary artery bypass grafting (e-cabg registry): study protocol for a prospective clinical registry and proposal of classification of postoperative complications
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485338/
https://www.ncbi.nlm.nih.gov/pubmed/26123033
http://dx.doi.org/10.1186/s13019-015-0292-z
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