CIBER-CLAP (CIBERCV Cardioprotection Large Animal Platform): A multicenter preclinical network for testing reproducibility in cardiovascular interventions.
Xavier RosselloAntonio Rodriguez-SinovasGemma VilahurVerónica CrisóstomoInmaculada JorgeCarlos ZaragozaJosé L ZamoranoJavier BermejoAntonio OrdoñezLisardo BoscáJesus VazquezLina BadimónFrancisco M Sánchez MargalloFrancisco Fernández-AvilésDavid Garcia-DoradoBorja IbanezPublished in: Scientific reports (2019)
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.
Keyphrases
- clinical trial
- open label
- acute myocardial infarction
- phase iii
- phase ii
- study protocol
- double blind
- placebo controlled
- physical activity
- heart failure
- type diabetes
- mass spectrometry
- metabolic syndrome
- randomized controlled trial
- squamous cell carcinoma
- cerebral ischemia
- ischemia reperfusion injury
- mesenchymal stem cells
- oxidative stress
- coronary artery disease
- brain injury
- subarachnoid hemorrhage
- insulin resistance
- photodynamic therapy
- blood brain barrier
- single cell