1. Multicentre translational Trial of Remote Ischaemic Conditioning in Acute Ischaemic Stroke (TRICS): protocol of multicentre, parallel group, randomised, preclinical trial in female and male rat and mouse from the Italian Stroke Organization (ISO) Basic Science network
- Author
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Diana Amantea, Luigi Sironi, Carlo Perego, Virginia Rogriguez-Menendez, Ilaria Dettori, Stefano Fumagalli, Maria Grazia De Simoni, Elisabetta Coppi, Giacinto Bagetta, Simone Beretta, Irene Bulli, Giorgia Serena Gullotta, Mauro Tettamanti, Joanna Rzemieniec, Antonio Vinciguerra, Laura Castiglioni, Susanna Diamanti, Carlo Ferrarese, Alessia Valente, Giuseppe Pignataro, Jacopo Mariani, Chiara Zoia, Martina Viganò, Marco Bacigaluppi, Felicita Pedata, Gianvito Martino, Francesco Santangelo, Tettamanti, M, Beretta, S, Pignataro, G, Fumagalli, S, Perego, C, Sironi, L, Pedata, F, Amantea, D, Bacigaluppi, M, Vinciguerra, A, Valente, A, Diamanti, S, Mariani, J, Viganò, M, Santangelo, F, Zoia, C, Rogriguez-Menendez, V, Castiglioni, L, Rzemieniec, J, Dettori, I, Bulli, I, Coppi, E, Gullotta, G, Bagetta, G, Martino, G, Ferrarese, C, De Simoni, M, Tettamanti, Mauro, Beretta, Simone, Pignataro, Giuseppe, Fumagalli, Stefano, Perego, Carlo, Sironi, Luigi, Pedata, Felicita, Amantea, Diana, Bacigaluppi, Marco, Vinciguerra, Antonio, Valente, Alessia, Diamanti, Susanna, Mariani, Jacopo, Viganò, Martina, Santangelo, Francesco, Zoia, Chiara Paola, Rogriguez-Menendez, Virginia, Castiglioni, Laura, Rzemieniec, Joanna, Dettori, Ilaria, Bulli, Irene, Coppi, Elisabetta, Gullotta, Giorgia Serena, Bagetta, Giacinto, Martino, Gianvito, Ferrarese, Carlo, and De Simoni, Maria Grazia
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Italian Stroke Organization (ISO) Basic Science ,Basic science ,neuroscore ,lcsh:Medicine ,MCA occlusion ,03 medical and health sciences ,0302 clinical medicine ,Occlusion ,Ischaemic stroke ,medicine ,Clinical endpoint ,Protocol ,TRICS, cerebral ischemia, Remote ischemic conditioning ,rat and mouse ,Stroke ,Protocol (science) ,business.industry ,lcsh:R ,Sham surgery ,General Medicine ,medicine.disease ,030104 developmental biology ,Infarct volume ,Physical therapy ,Remote ischaemic conditioning (RIC) ,Settore BIO/14 - Farmacologia ,Settore MED/26 - Neurologia ,business ,sperimental stroke ,030217 neurology & neurosurgery - Abstract
Introduction Multicentre preclinical randomised controlled trials (pRCT) are emerging as a necessary step to confirm efficacy and improve translation into the clinic. The aim of this project is to perform two multicentre pRCTs (one in rats and one in mice) to investigate the efficacy of remote ischaemic conditioning (RIC) in an experimental model of severe ischaemic stroke. Methods and analysis Seven research laboratories within the Italian Stroke Organization (ISO) Basic Science network will participate in the study. Transient endovascular occlusion of the proximal right middle cerebral artery will be performed in two species (rats and mice) and in both sexes. Animals will be randomised to receive RIC by transient surgical occlusion of the right femoral artery, or sham surgery, after reperfusion. Blinded outcome assessment will be performed for dichotomised functional neuroscore (primary endpoint) and infarct volume (secondary endpoint) at 48 hours. A sample size of 80 animals per species will yield 82% power to detect a significant difference of 30% in the primary outcome in both pRCTs. Analyses will be performed in a blind status and according to an intention-to-treat paradigm. The results of this study will provide robust, translationally oriented, high-quality evidence on the efficacy of RIC in multiple species of rodents with large ischaemic stroke. Ethics and dissemination This is approved by the Animal Welfare Regulatory Body of the University of Milano Bicocca, under project license from the Italian Ministry of Health. Trial results will be subject to publication according to the definition of the outcome presented in this protocol. Trial registration number PCTE0000177.
- Published
- 2020