REMOTE ischemic perconditioning among acute ischemic stroke patients in Catalonia: REMOTE-CAT PROJECT

Purroy, Francisco; Arque, Gloria; Mauri, Gerard; García-Vázquez, Cristina; Vicente-Pascual, Mikel; Pereira, Cristina; Vázquez-Justes, Daniel; Torres-Querol, Coral; Vena, Ana; Abilleira, Sonia; Cardona, Pere; Forné, Carles; Jiménez-Fàbrega, Xavier; Pagola, Jorge; Portero Otín, Manuel; Rodríguez-Campello, Ana; Rovira, Alex; Martí-Fàbregas, Joan

REMOTE ischemic perconditioning among acute ischemic stroke patients in Catalonia: REMOTE-CAT PROJECT

Mostra el registre complet Registre parcial de l'ítem

dc.contributor.author Purroy, Francisco
dc.contributor.author Arque, Gloria
dc.contributor.author Mauri, Gerard
dc.contributor.author García-Vázquez, Cristina
dc.contributor.author Vicente-Pascual, Mikel
dc.contributor.author Pereira, Cristina
dc.contributor.author Vázquez-Justes, Daniel
dc.contributor.author Torres-Querol, Coral
dc.contributor.author Vena, Ana
dc.contributor.author Abilleira, Sonia
dc.contributor.author Cardona, Pere
dc.contributor.author Forné, Carles
dc.contributor.author Jiménez-Fàbrega, Xavier
dc.contributor.author Pagola, Jorge
dc.contributor.author Portero Otín, Manuel
dc.contributor.author Portero Otín, Manuel
dc.contributor.author Rodríguez-Campello, Ana
dc.contributor.author Rovira, Alex
dc.contributor.author Martí-Fàbregas, Joan
dc.date.accessioned 2021-07-02T06:52:29Z
dc.date.available 2021-07-02T06:52:29Z
dc.date.issued 2020
dc.description.abstract Rationale: Remote ischemic perconditioning during cerebral ischemia (RIPerC) refers to the application of brief episodes of transient limb ischemia commonly to a limb, it represents a new safe, simple and low-cost paradigm in neuroprotection. Aim and/or Hypothesis: To evaluate the effects of RIPerC on acute ischemic stroke (AIS) patients, applied in the ambulance, to improve functional outcomes compared with standard of care. Sample Size Estimates: A sample size of 286 patients in each arm achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%. Methods and Design: We aim to conduct a multicentre study of pre-hospital RIPerC application in AIS patients. A total of 572 adult patients diagnosed of suspected clinical stroke within 8 h of symptom onset and clinical deficit >0 according to prehospital rapid arterial occlusion evaluation (RACE) scale score will be randomized, in blocks of size 4, to RIPerC or sham. Patients will be stratified by RACE score scale. RIPerC will be started in the ambulance before hospital admission and continued in the hospital if necessary. It will consist of five cycles of electronic tourniquet inflation and deflation (5 min each). The cuff pressure for RIPerC will be 200 mmHg during inflation. Sham will only simulate vibration of the device. Study Outcome(s): The primary outcome will be the difference in the proportion of patients with good outcomes as defined by a mRS score of 2 or less at 90 days. Secondary outcomes to be monitored will include early neurological improvement rate, treatment related serious adverse event rates, size of the infarct volume, symptomatic intracranial hemorrhage, metabolomic and lipidomic response to RIPerC and Neuropsychological evaluation at 90 days. Discussion: Neuroprotective therapies could not only increase the benefits of available reperfusion therapies among AIS patients but also provide an option for patients who are not candidates for these treatments. REMOTE-CAT will investigate the clinical benefit of RIC as a new neuroprotective strategy in AIS. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03375762.
dc.format.mimetype application/pdf
dc.identifier.citation Purroy F, Arque G, Mauri G, García-Vázquez C, Vicente-Pascual M, Pereira C, et al. REMOTE ischemic perconditioning among acute ischemic stroke patients in Catalonia: REMOTE-CAT PROJECT. Front Neurol. 2020 Sep 25; 11: 569696. DOI: 10.3389/fneur.2020.569696
dc.identifier.doi http://dx.doi.org/10.3389/fneur.2020.569696
dc.identifier.issn 1664-2295
dc.identifier.uri http://hdl.handle.net/10230/48066
dc.language.iso eng
dc.publisher Frontiers
dc.rights Copyright © 2020 Purroy, Arque, Mauri, García-Vázquez, Vicente-Pascual, Pereira, Vazquez-Justes, Torres-Querol, Vena, Abilleira, Cardona, Forné, Jiménez-Fàbrega, Pagola, Portero-Otin, Rodríguez-Campello, Rovira and Martí-Fàbregas. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) http://creativecommons.org/licenses/by/4.0/. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.keyword Infarct size (IS)
dc.subject.keyword Ischemic stroke
dc.subject.keyword Metabolomics (OMICS)
dc.subject.keyword Neuroprotection
dc.subject.keyword Remote ischemic perconditioning (rPerC)
dc.title REMOTE ischemic perconditioning among acute ischemic stroke patients in Catalonia: REMOTE-CAT PROJECT
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

Col·leccions

Articles (Hospital del Mar Research Institute)