Simone Beretta, Mauro Tettamanti, Jacopo Mariani, Susanna Diamanti, Alessia Valente, Ornella Cuomo, Chiara Di Santo, Ilaria Dettori, Martina Venturini, Irene Bulli, Elisabetta Coppi, Manuel Alejandro Montano Castillo, Erica Butti, Giorgia Serena Gullotta, Martina Viganò, Francesco Santangelo, Francesco Andrea Pedrazzini, Carlo Perego, Serena Seminara, Serenella Anzilotti, Joanna Rzemieniec, Laura Castiglioni, Benedetta Mercuriali, Majeda Muluhie, Chiara Paola Zoia, Gessica Sala, Luigi Sironi, Marco Bacigaluppi, Gianvito Martino, Felicita Pedata, Anna Maria Pugliese, Diana Amantea, Giacinto Bagetta, Antonio Vinciguerra, Giuseppe Pignataro, Stefano Fumagalli, Maria-Grazia De Simoni, Carlo Ferrarese
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The TRICS BASIC study (Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke) investigated the efficacy and safety of RIC in experimental ischemic stroke using a rigorous clinical trial methodology.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i>=0.009). RIC was associated with a small reduction in infarct volume (standardized mean difference, -0.38 [95% CI, -0.70 to -0.05]; <i>P</i>=0.024). Health monitoring indicated no major safety concerns, and postoperative analgesia requirements were lower in RIC-treated mice.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.preclinicaltrials.eu; Unique identifier: PCTE0000177.</p>","PeriodicalId":21989,"journal":{"name":"Stroke","volume":" ","pages":""},"PeriodicalIF":8.9000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke (TRICS BASIC).\",\"authors\":\"Simone Beretta, Mauro Tettamanti, Jacopo Mariani, Susanna Diamanti, Alessia Valente, Ornella Cuomo, Chiara Di Santo, Ilaria Dettori, Martina Venturini, Irene Bulli, Elisabetta Coppi, Manuel Alejandro Montano Castillo, Erica Butti, Giorgia Serena Gullotta, Martina Viganò, Francesco Santangelo, Francesco Andrea Pedrazzini, Carlo Perego, Serena Seminara, Serenella Anzilotti, Joanna Rzemieniec, Laura Castiglioni, Benedetta Mercuriali, Majeda Muluhie, Chiara Paola Zoia, Gessica Sala, Luigi Sironi, Marco Bacigaluppi, Gianvito Martino, Felicita Pedata, Anna Maria Pugliese, Diana Amantea, Giacinto Bagetta, Antonio Vinciguerra, Giuseppe Pignataro, Stefano Fumagalli, Maria-Grazia De Simoni, Carlo Ferrarese\",\"doi\":\"10.1161/STROKEAHA.125.051532\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Basic science studies have reported remote ischemic conditioning (RIC) as neuroprotective in acute ischemic stroke, although clinical evidence remains conflicting. The TRICS BASIC study (Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke) investigated the efficacy and safety of RIC in experimental ischemic stroke using a rigorous clinical trial methodology.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i>=0.009). RIC was associated with a small reduction in infarct volume (standardized mean difference, -0.38 [95% CI, -0.70 to -0.05]; <i>P</i>=0.024). Health monitoring indicated no major safety concerns, and postoperative analgesia requirements were lower in RIC-treated mice.</p><p><strong>Conclusions: </strong>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. 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Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke (TRICS BASIC).
Background: Basic science studies have reported remote ischemic conditioning (RIC) as neuroprotective in acute ischemic stroke, although clinical evidence remains conflicting. The TRICS BASIC study (Multicenter Translational Trial of Remote Ischemic Conditioning in Acute Ischemic Stroke) investigated the efficacy and safety of RIC in experimental ischemic stroke using a rigorous clinical trial methodology.
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.
期刊介绍：
Stroke is a monthly publication that collates reports of clinical and basic investigation of any aspect of the cerebral circulation and its diseases. The publication covers a wide range of disciplines including anesthesiology, critical care medicine, epidemiology, internal medicine, neurology, neuro-ophthalmology, neuropathology, neuropsychology, neurosurgery, nuclear medicine, nursing, radiology, rehabilitation, speech pathology, vascular physiology, and vascular surgery.
The audience of Stroke includes neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists.
Stroke is indexed in Biological Abstracts, BIOSIS, CAB Abstracts, Chemical Abstracts, CINAHL, Current Contents, Embase, MEDLINE, and Science Citation Index Expanded.
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