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Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial).doc

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Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial)

Brevoordetal.BMCAnesthesiology2011,11:11 /1471-2253/11/11 STUDY PROTOCOL OpenAccess Effectofremoteischemicconditioningonatrial fibrillationandoutcomeaftercoronaryartery bypassgrafting(RICO-trial) DanielBrevoord1,MarkusWHollmann1,StefanGDeHert1,EricHPAvanDongen2,BramGADHHeijnen2, AntondeBruin2,NoortjeTolenaar2,WolfgangSSchlack1,NinaCWeber1,MarcelGWDijkgraaf3,JorisRdeGroot4, BasAJMdeMol5,AntoineHGDriessen5,MonaMomeni6,PatrickWouters7,StefaanBouchez7,JanHofland8, ChristanLüthen8,TanjaAMeijer-Treschan9,BenediktHPannen9andBenediktPreckel1* Abstract Background:Pre-andpostconditioningdescribemechanismswherebyshortischemicperiodsprotectanorgan againstalongerperiodofischemia.Interestingly,shortischemicperiodsofalimb,initselfharmless,mayincrease theischemiatoleranceofremoteorgans,e.g.theheart(remoteconditioning,RC).Althoughseveralstudieshave shownreducedbiomarkerreleasebyRC,areductionofcomplicationsandimprovementofpatientoutcomestill hastobedemonstrated.Atrialfibrillation(AF)isoneofthemostcommoncomplicationsaftercoronaryartery bypassgraftsurgery(CABG),affecting27-46%ofpatients.Itisassociatedwithincreasedmortality,adverse cardiovascularevents,andprolongedin-hospitalstay.Wehypothesizethatremoteischemicpre-and/orpost- conditioningreducetheincidenceofAFfollowingCABG,andimprovepatientoutcome. Methods/design:Thisstudyisarandomized,controlled,patientandinvestigatorblindedmulticentertrial.Elective CABGpatientsarerandomizedtooneofthefollowingfourgroups:1)control,2)remoteischemicpreconditioning, 3)remoteischemicpostconditioning,or4)remoteischemicpre-andpostconditioning.Remoteconditioningis appliedatthearmby3cyclesof5minutesofischemiaandreperfusion.PrimaryendpointistheincidenceAFin thefirst72hoursaftersurgery,detectedusingaHolter-monitor.Secondaryendpointsincludelength-of-stayonthe intensivecareunitandin-hospital,andtheoccurrenceofmajoradversecardiovasculareventsat30days,3months and1year. Basedonanexpectedincidenceinthecontrolgroupof27%,195patientspergroupareneededtodetectwith 80%powera