Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke (TRICS BASIC).
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Beretta Simone, Tettamanti Mauro, Mariani Jacopo, Diamanti Susanna, Valente Alessia, Cuomo Ornella, Di Santo Chiara, Dettori Ilaria, Venturini Martina, Bulli Irene, Coppi Elisabetta, Montano Castillo Manuel Alejandro, Butti Erica, Gullotta Giorgia Serena, Viganò Martina, Santangelo Francesco, Pedrazzini Francesco Andrea, Perego Carlo, Seminara Serena, Anzilotti Serenella, Rzemieniec Joanna, Castiglioni Laura, Mercuriali Benedetta, Muluhie Majeda, Zoia Chiara Paola, Sala Gessica, Sironi Luigi, Bacigaluppi Marco, Martino Gianvito, Pedata Felicita, Pugliese Anna Maria, Amantea Diana, Bagetta Giacinto, Vinciguerra Antonio, Pignataro Giuseppe, Fumagalli Stefano, De Simoni Maria-Grazia, Ferrarese Carlo
Аннотация
METHODS: Multicenter, multispecies, parallel group, randomized, controlled, preclinical trial of transient femoral artery clipping to induce RIC in female and male rats and mice subjected to transient endovascular occlusion of the middle cerebral artery. Animals were randomized to receive RIC, or sham surgery, after reperfusion. The primary end point was a good functional outcome at 48 hours, assessed using a composite functional neuroscore. Secondary end points were infarct volume at 48 hours and safety, assessed using a standardized health report at 24 and 48 hours. Preenrollment harmonization, centralized monitoring, allocation concealment, blinded outcome assessment, and intention-to-treat analysis were applied.
RESULTS: The trial enrolled 164 rodents (82 mice and 82 rats) of both sexes (53% females), across 7 laboratories. A greater proportion of RIC-treated rodents achieved a favorable functional outcome compared with controls, at 48 hours postischemia (55% versus 36%; odds ratio, 2.2 [95% CI, 1.23-4.4]; P=0.009). RIC was associated with a small reduction in infarct volume (standardized mean difference, -0.38 [95% CI, -0.70 to -0.05]; P=0.024). Health monitoring indicated no major safety concerns, and postoperative analgesia requirements were lower in RIC-treated mice.
CONCLUSIONS: Surgically induced RIC provided a modest but evident neuroprotective effect in experimental ischemic stroke, underscoring the potential of this strategy as an adjunctive treatment in stroke care. The findings of the TRICS BASIC study highlighted the importance of multicenter preclinical trials in addressing variability and enhancing translational validity.
REGISTRATION: URL: https://www.preclinicaltrials.eu; Unique identifier: PCTE0000177.