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.
Journal
BMJ open science
ISSN: 2398-8703
Titre abrégé: BMJ Open Sci
Pays: England
ID NLM: 101778290
Informations de publication
Date de publication:
2020
2020
Historique:
received:
22
02
2020
revised:
15
09
2020
accepted:
06
10
2020
entrez:
20
1
2022
pubmed:
24
11
2020
medline:
24
11
2020
Statut:
epublish
Résumé
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. 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. 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. PCTE0000177.
Identifiants
pubmed: 35047692
doi: 10.1136/bmjos-2020-100063
pii: bmjos-2020-100063
pmc: PMC8647600
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e100063Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Int J Stroke. 2009 Dec;4(6):471-9
pubmed: 19930059
Stroke. 2017 Jul;48(7):2007-2012
pubmed: 28626052
Lancet Neurol. 2017 Mar;16(3):217-226
pubmed: 28229893
Sci Transl Med. 2015 Aug 5;7(299):299fs32
pubmed: 26246165
Nature. 2012 Oct 11;490(7419):187-91
pubmed: 23060188
J Neurochem. 2016 Oct;139 Suppl 2:271-279
pubmed: 26968835
BMJ. 2005 Apr 30;330(7498):977-8
pubmed: 15860802
Stroke. 2017 May;48(5):1412-1415
pubmed: 28265014
J Cereb Blood Flow Metab. 2008 Feb;28(2):232-41
pubmed: 17882162
J Cereb Blood Flow Metab. 2017 Nov;37(11):3488-3517
pubmed: 28797196
Sci Rep. 2017 Jul 31;7(1):6962
pubmed: 28761170
J Biomed Inform. 2019 Jul;95:103208
pubmed: 31078660
Circulation. 2012 Sep 18;126(12):1484-94
pubmed: 22879370
Neurobiol Dis. 2013 Jun;54:105-14
pubmed: 23454199
Stroke. 2016 Aug;47(8):2148-53
pubmed: 27354221
Nat Rev Neurol. 2015 Dec;11(12):698-710
pubmed: 26585977
Int J Stroke. 2016 Oct;11(8):938-943
pubmed: 27412192
Sci Transl Med. 2015 Aug 5;7(299):299ra121
pubmed: 26246166
Cell Mol Immunol. 2020 Mar;17(3):218-226
pubmed: 30967639
J Am Heart Assoc. 2019 Dec 3;8(23):e013572
pubmed: 31747864
Stroke. 2014 Jan;45(1):159-67
pubmed: 24203849