CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions

Abstract Despite many cardioprotective interventions have shown to protect the heart against ischemia/reperfusion injury in the experimental setting, only few of them have succeeded in translating their findings into positive proof-of-concept clinical trials. Controversial and inconsistent experimen...

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Autores principales:	Xavier Rossello, Antonio Rodriguez-Sinovas, Gemma Vilahur, Verónica Crisóstomo, Inmaculada Jorge, Carlos Zaragoza, José L. Zamorano, Javier Bermejo, Antonio Ordoñez, Lisardo Boscá, Jesús Vázquez, Lina Badimón, Francisco M. Sánchez-Margallo, Francisco Fernández-Avilés, David Garcia-Dorado, Borja Ibanez
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2019
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/b7451e7937ac4d0583664f00519c9d62
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spelling	oai:doaj.org-article:b7451e7937ac4d0583664f00519c9d622021-12-02T15:12:47ZCIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions10.1038/s41598-019-56613-62045-2322https://doaj.org/article/b7451e7937ac4d0583664f00519c9d622019-12-01T00:00:00Zhttps://doi.org/10.1038/s41598-019-56613-6https://doaj.org/toc/2045-2322Abstract Despite many cardioprotective interventions have shown to protect the heart against ischemia/reperfusion injury in the experimental setting, only few of them have succeeded in translating their findings into positive proof-of-concept clinical trials. Controversial and inconsistent experimental and clinical evidence supports the urgency of a disruptive paradigm shift for testing cardioprotective therapies. There is a need to evaluate experimental reproducibility before stepping into the clinical arena. The CIBERCV (acronym for Spanish network-center for cardiovascular biomedical research) has set up the “Cardioprotection Large Animal Platform” (CIBER-CLAP) to perform experimental studies testing the efficacy and reproducibility of promising cardioprotective interventions based on a pre-specified design and protocols, randomization, blinding assessment and other robust methodological features. Our first randomized, control-group, open-label blinded endpoint experimental trial assessing local ischemic preconditioning (IPC) in a pig model of acute myocardial infarction (n = 87) will be carried out in three separate sets of experiments performed in parallel by three laboratories. Each set aims to assess: (A) CMR-based outcomes; (B) histopathological-based outcomes; and (C) protein-based outcomes. Three core labs will assess outcomes in a blinded fashion (CMR imaging, histopathology and proteomics) and 2 methodological core labs will conduct the randomization and statistical analysis.Xavier RosselloAntonio Rodriguez-SinovasGemma VilahurVerónica CrisóstomoInmaculada JorgeCarlos ZaragozaJosé L. ZamoranoJavier BermejoAntonio OrdoñezLisardo BoscáJesús VázquezLina BadimónFrancisco M. Sánchez-MargalloFrancisco Fernández-AvilésDavid Garcia-DoradoBorja IbanezNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 9, Iss 1, Pp 1-11 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Xavier Rossello Antonio Rodriguez-Sinovas Gemma Vilahur Verónica Crisóstomo Inmaculada Jorge Carlos Zaragoza José L. Zamorano Javier Bermejo Antonio Ordoñez Lisardo Boscá Jesús Vázquez Lina Badimón Francisco M. Sánchez-Margallo Francisco Fernández-Avilés David Garcia-Dorado Borja Ibanez CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
description	Abstract Despite many cardioprotective interventions have shown to protect the heart against ischemia/reperfusion injury in the experimental setting, only few of them have succeeded in translating their findings into positive proof-of-concept clinical trials. Controversial and inconsistent experimental and clinical evidence supports the urgency of a disruptive paradigm shift for testing cardioprotective therapies. There is a need to evaluate experimental reproducibility before stepping into the clinical arena. The CIBERCV (acronym for Spanish network-center for cardiovascular biomedical research) has set up the “Cardioprotection Large Animal Platform” (CIBER-CLAP) to perform experimental studies testing the efficacy and reproducibility of promising cardioprotective interventions based on a pre-specified design and protocols, randomization, blinding assessment and other robust methodological features. Our first randomized, control-group, open-label blinded endpoint experimental trial assessing local ischemic preconditioning (IPC) in a pig model of acute myocardial infarction (n = 87) will be carried out in three separate sets of experiments performed in parallel by three laboratories. Each set aims to assess: (A) CMR-based outcomes; (B) histopathological-based outcomes; and (C) protein-based outcomes. Three core labs will assess outcomes in a blinded fashion (CMR imaging, histopathology and proteomics) and 2 methodological core labs will conduct the randomization and statistical analysis.
format	article
author	Xavier Rossello Antonio Rodriguez-Sinovas Gemma Vilahur Verónica Crisóstomo Inmaculada Jorge Carlos Zaragoza José L. Zamorano Javier Bermejo Antonio Ordoñez Lisardo Boscá Jesús Vázquez Lina Badimón Francisco M. Sánchez-Margallo Francisco Fernández-Avilés David Garcia-Dorado Borja Ibanez
author_facet	Xavier Rossello Antonio Rodriguez-Sinovas Gemma Vilahur Verónica Crisóstomo Inmaculada Jorge Carlos Zaragoza José L. Zamorano Javier Bermejo Antonio Ordoñez Lisardo Boscá Jesús Vázquez Lina Badimón Francisco M. Sánchez-Margallo Francisco Fernández-Avilés David Garcia-Dorado Borja Ibanez
author_sort	Xavier Rossello
title	CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
title_short	CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
title_full	CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
title_fullStr	CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
title_full_unstemmed	CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
title_sort	ciber-clap (cibercv cardioprotection large animal platform): a multicenter preclinical network for testing reproducibility in cardiovascular interventions
publisher	Nature Portfolio
publishDate	2019
url	https://doaj.org/article/b7451e7937ac4d0583664f00519c9d62
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CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions

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