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Sci Rep. 2019 Dec 30;9(1):20290. doi: 10.1038/s41598-019-56613-6.

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

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Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Laboratorio de Investigación en Enfermedades Cardiovasculares, Vall d'Hebron Institut de Recerca, Barcelona, Spain.
Programa ICCC-Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, Barcelona, Spain.
Centro de Cirugía de Mínima Invasión Jesús Usón, Cáceres, Spain.
Servicio de Cardiologia, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.
Universidad Francisco de Vitoria, Madrid, Spain.
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón and Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Instituto de Biomedicina de Sevilla, Sevilla, Spain.
Instituto de Investigaciones Biomédicas Alberto Sols (Centro Mixto CSIC-UAM), Madrid, Spain.
Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Cardiology Department, IIS-Fundación Jiménez Díaz Hospital, Madrid, Spain.


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.

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