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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.

Author information

1
Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
2
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
3
Laboratorio de Investigación en Enfermedades Cardiovasculares, Vall d'Hebron Institut de Recerca, Barcelona, Spain.
4
Programa ICCC-Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, Barcelona, Spain.
5
Centro de Cirugía de Mínima Invasión Jesús Usón, Cáceres, Spain.
6
Servicio de Cardiologia, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.
7
Universidad Francisco de Vitoria, Madrid, Spain.
8
Department of Cardiology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón and Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
9
Instituto de Biomedicina de Sevilla, Sevilla, Spain.
10
Instituto de Investigaciones Biomédicas Alberto Sols (Centro Mixto CSIC-UAM), Madrid, Spain.
11
Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain. bibanez@cnic.es.
12
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. bibanez@cnic.es.
13
Cardiology Department, IIS-Fundación Jiménez Díaz Hospital, Madrid, Spain. bibanez@cnic.es.

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.

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