Please use this identifier to cite or link to this item:http://hdl.handle.net/20.500.12105/8988
CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions
Rossello, Xavier CNIC | Rodriguez-Sinovas, Antonio | Vilahur, Gemma | Crisóstomo, Verónica | Jorge, Inmaculada CNIC | Zaragoza, Carlos CNIC | Zamorano, José L | Bermejo, Javier | Ordoñez, Antonio | Boscá, Lisardo | Vazquez, Jesus CNIC | Badimón, Lina | Sánchez-Margallo, Francisco M | Fernández-Avilés, Francisco | Garcia-Dorado, David | Ibanez, Borja CNIC
Sci Rep. 2019; 9(1):20290
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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