Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial

Gašparović, Hrvoje and Kopjar, Tomislav and Radoš, Milan and Antičević, Alan and Radoš, Marko and Malojčić, Branko and Ivančan, Višnja and Fabijanić, Tea and Čikeš, Maja and Miličić, Davor and Gašparović, Vladimir and Biočina, Bojan (2014) Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. Trials, 15 (1). p. 414. ISSN 1745-6215

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Članak je dostupan u skladu s odredbama licencije o slobodnom pristupu izdavača BioMed Central ( ----- THE WORK IS PROVIDED UNDER THE TERMS OF THIS BIOMED CENTRAL OPEN ACCESS LICENSE. THE WORK IS PROTECTED BY COPYRIGHT AND/OR OTHER APPLICABLE LAW. ANY USE OF THE WORK OTHER THAN AS AUTHORIZED UNDER THIS LICENSE IS PROHIBITED ( ----- BACKGROUND: Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life. The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population. Remote ischemic preconditioning (RIPC) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion. This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena, by employing magnetic resonance imaging (MRI) and neurocognitive testing. ----- METHODS: Patients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study. Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure. The RIPC will be induced by inflation of a blood pressure cuff to 200 mmHg for 5 minutes, followed by a 5-minute reperfusion period. Three sequences of interchanging cuff inflations and deflations will be employed. Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day 7. Paired pre- and postoperative neurocognitive and neuroimaging data will then be compared. The primary composite outcome measure will consist of new ischemic lesions on brain MRI, postprocedural impairment in brain connectivity on resting-state functional MRI (rs-fMRI), and significant new declines in neurocognitive performance. The secondary endpoint measures will be the individual components of the primary endpoint measures, expressed as continuous variables, troponin T release on postoperative day 1 and the incidence of major adverse cardiovascular events at 3 months postoperatively. Major adverse cardiovascular events, including accumulating cardiovascular mortality, stroke, nonfatal myocardial infarction, and rehospitalization for ischemia, will form a composite endpoint measure. ----- DISCUSSION: This trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response. Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting, it could impact on the current standard of care.

Item Type: Article
MeSH: Cardiopulmonary Bypass/adverse effects ; Cerebrovascular Circulation ; Cerebrovascular Disorders/diagnosis ; Cerebrovascular Disorders/physiopathology ; Cerebrovascular Disorders/prevention & control ; Cerebrovascular Disorders/psychology ; Clinical Protocols ; Coronary Artery Bypass/adverse effects ; Coronary Artery Disease/diagnosis ; Coronary Artery Disease/physiopathology ; Coronary Artery Disease/surgery ; Croatia ; Double-Blind Method ; Elective Surgical Procedures ; Humans ; Ischemic Preconditioning/adverse effects ; Ischemic Preconditioning/methods ; Magnetic Resonance Imaging ; Neuropsychological Tests ; Prospective Studies ; Regional Blood Flow ; Research Design ; Time Factors ; Treatment Outcome ; Upper Extremity/blood supply
Departments: Hrvatski institut za istraživanje mozga
Katedra za internu medicinu
Katedra za kirurgiju
Katedra za neurologiju
Katedra za radiologiju i opću kliničku onkologiju
Depositing User: Marijan Šember
Status: Published
Gašparović, HrvojeUNSPECIFIED
Kopjar, TomislavUNSPECIFIED
Antičević, AlanUNSPECIFIED
Malojčić, BrankoUNSPECIFIED
Ivančan, VišnjaUNSPECIFIED
Gašparović, VladimirUNSPECIFIED
Date: 27 October 2014
Date Deposited: 18 Sep 2015 10:57
Last Modified: 18 Sep 2015 10:57
Subjects: /
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