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Published in: Basic Research in Cardiology 5/2018

Open Access 01-09-2018 | Practical Guideline

Practical guidelines for rigor and reproducibility in preclinical and clinical studies on cardioprotection

Authors: Hans Erik Bøtker, Derek Hausenloy, Ioanna Andreadou, Salvatore Antonucci, Kerstin Boengler, Sean M. Davidson, Soni Deshwal, Yvan Devaux, Fabio Di Lisa, Moises Di Sante, Panagiotis Efentakis, Saveria Femminò, David García-Dorado, Zoltán Giricz, Borja Ibanez, Efstathios Iliodromitis, Nina Kaludercic, Petra Kleinbongard, Markus Neuhäuser, Michel Ovize, Pasquale Pagliaro, Michael Rahbek-Schmidt, Marisol Ruiz-Meana, Klaus-Dieter Schlüter, Rainer Schulz, Andreas Skyschally, Catherine Wilder, Derek M. Yellon, Peter Ferdinandy, Gerd Heusch

Published in: Basic Research in Cardiology | Issue 5/2018

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Excerpt

The potential for ischemic preconditioning to reduce infarct size was first recognized more than 30 years ago [180]. Despite extension of the concept to ischemic postconditioning [460] and remote ischemic conditioning [202, 344] and literally thousands of experimental studies in various species and models which identified a multitude of signaling steps [199], so far there is only a single and very recent study, which has unequivocally translated cardioprotection to improved clinical outcome as the primary endpoint in patients [155, 200]. Many potential reasons for this disappointing lack of clinical translation of cardioprotection have been proposed, including lack of rigor and reproducibility in preclinical studies [54, 195], and poor design and conduct of clinical trials [196, 206]. There is, however, universal agreement that robust preclinical data are a mandatory prerequisite to initiate a meaningful clinical trial. In this context, it is disconcerting that the CAESAR consortium (Consortium for preclinicAl assESsment of cARdioprotective therapies) in a highly standardized multi-center approach of preclinical studies identified only ischemic preconditioning, but not nitrite or sildenafil, when given as adjunct to reperfusion, to reduce infarct size [230]. However, ischemic preconditioning—due to its very nature—can only be used in elective interventions, and not in acute myocardial infarction [181, 197, 203]. Therefore, better strategies to identify robust and reproducible strategies of cardioprotection, which can subsequently be tested in clinical trials must be developed [184]. We refer to the recent guidelines for experimental models of myocardial ischemia and infarction [279], and aim to provide now practical guidelines to ensure rigor and reproducibility in preclinical and clinical studies on cardioprotection. In line with the above guidelines [279], we define rigor as standardized state-of-the-art design, conduct and reporting of a study, which is then a prerequisite for reproducibility, i.e. replication of results by another laboratory when performing exactly the same experiment. …
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Metadata
Title
Practical guidelines for rigor and reproducibility in preclinical and clinical studies on cardioprotection
Authors
Hans Erik Bøtker
Derek Hausenloy
Ioanna Andreadou
Salvatore Antonucci
Kerstin Boengler
Sean M. Davidson
Soni Deshwal
Yvan Devaux
Fabio Di Lisa
Moises Di Sante
Panagiotis Efentakis
Saveria Femminò
David García-Dorado
Zoltán Giricz
Borja Ibanez
Efstathios Iliodromitis
Nina Kaludercic
Petra Kleinbongard
Markus Neuhäuser
Michel Ovize
Pasquale Pagliaro
Michael Rahbek-Schmidt
Marisol Ruiz-Meana
Klaus-Dieter Schlüter
Rainer Schulz
Andreas Skyschally
Catherine Wilder
Derek M. Yellon
Peter Ferdinandy
Gerd Heusch
Publication date
01-09-2018
Publisher
Springer Berlin Heidelberg
Published in
Basic Research in Cardiology / Issue 5/2018
Print ISSN: 0300-8428
Electronic ISSN: 1435-1803
DOI
https://doi.org/10.1007/s00395-018-0696-8

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