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dc.contributor.authorAnstensrud, Anne Kristine
dc.contributor.authorWoxholt, Sindre
dc.contributor.authorSharma, Kapil Kishore
dc.contributor.authorBroch, Kaspar
dc.contributor.authorBendz, Bjørn
dc.contributor.authorAakhus, Svend
dc.contributor.authorUeland, Thor
dc.contributor.authorAmundsen, Brage H.
dc.contributor.authorDamås, Jan Kristian
dc.contributor.authorHopp, Einar
dc.contributor.authorKleveland, Ola
dc.contributor.authorSTENSÆTH, KNUT HAAKON
dc.contributor.authorOpdahl, Anders
dc.contributor.authorKløw, Nils-Einar
dc.contributor.authorSeljeflot, Ingebjørg
dc.contributor.authorAndersen, Geir Øystein
dc.contributor.authorWiseth, Rune
dc.contributor.authorAukrust, Pål
dc.contributor.authorGullestad, Lars
dc.description.abstractIntroduction Interleukin-6 (IL-6) may be involved in ischaemia-reperfusion injury and myocardial remodelling after myocardial infarction (MI). We have recently shown that IL-6 inhibition by tocilizumab attenuates systemic inflammation and troponin T-release in patients with acute non-ST elevation MI (NSTEMI). Experimental studies suggest that IL-6 inhibition can limit infarct size through anti-inflammatory mechanisms, but this has not been tested in clinical studies. With the ASSessing the effect of Anti-IL-6 treatment in MI (ASSAIL-MI) trial, we aim to examine whether a single administration of the IL-6 receptor antagonist tocilizumab can increase myocardial salvage in patients with acute ST-elevation MI (STEMI). Methods and analysis The ASSAIL-MI trial is a randomised, double blind, placebo-controlled trial, conducted at three high-volume percutaneous coronary intervention (PCI) centres in Norway. 200 patients with first-time STEMI presenting within 6 hours of the onset of chest pain will be randomised to receive tocilizumab or matching placebo prior to PCI. The patients are followed-up for 6 months. The primary endpoint is the myocardial salvage index measured by cardiac MRI (CMR) 3–7 days after the intervention. Secondary endpoints include final infarct size measured by CMR and plasma markers of myocardial necrosis. Efficacy and safety assessments during follow-up include blood sampling, echocardiography and CMR. Ethics and dissemination Based on previous experience the study is considered feasible and safe. If tocilizumab increases myocardial salvage, further endpoint-driven multicentre trials may be initiated. The ASSAIL-MI trial has the potential to change clinical practice in patients with STEMI. Registration, identifier NCT03004703.nb_NO
dc.publisherBMJ Publishing Groupnb_NO
dc.rightsNavngivelse-Ikkekommersiell 4.0 Internasjonal*
dc.titleRationale for the ASSAIL-MI-trial: a randomised controlled trial designed to assess the effect of tocilizumab on myocardial salvage in patients with acute ST-elevation myocardial infarction (STEMI).nb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.source.journalOpen heartnb_NO
dc.description.localcode© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.nb_NO
cristin.unitnameInstitutt for sirkulasjon og bildediagnostikk
cristin.unitnameInstitutt for klinisk og molekylær medisin

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Navngivelse-Ikkekommersiell 4.0 Internasjonal
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