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

BMC Anesthesiology

Study Protocol

Marcel GW Dijkgraaf¹  Benedikt H Pannen²  Tanja A Meijer-Treschan²  Jan Hofland³  Christan Lüthen³  Nina C Weber⁴  Benedikt Preckel⁴  Wolfgang S Schlack⁴  Daniel Brevoord⁴  Markus W Hollmann⁴  Stefan G De Hert⁴  Noortje Tolenaar⁵  Anton de Bruin⁵  Eric HPA van Dongen⁵  Bram GADH Heijnen⁵  Mona Momeni⁶  Patrick Wouters⁷  Stefaan Bouchez⁷  Joris R de Groot⁸  Antoine HG Driessen⁹  Bas AJM de Mol⁹ 

[1] Clinical Research Unit, Academic Medical Centre Amsterdam, The Netherlands;Department of Anaesthesiology and Intensive Care, University Hospital Düsseldorf, Germany;Department of Anaesthesiology, Erasmus Medical Centre Rotterdam, The Netherlands;Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Academic Medical Centre, Amsterdam, The Netherlands;Department of Anaesthesiology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands;Department of Anaesthesiology, UCL Brussels, Belgium;Department of Anaesthesiology, UZ Gent, The Netherlands;Department of Cardiology, Academic Medical Centre Amsterdam, The Netherlands;Department of Cardiothoracic Surgery, Academic Medical Centre Amsterdam, The Netherlands;

关键词: Atrial Fibrillation;    Coronary Artery Bypass Graft;    Major Adverse Cardiac Event;    Coronary Artery Bypass Graft Patient;    Postoperative Atrial Fibrillation;   

DOI  :  10.1186/1471-2253-11-11

 received in 2011-01-06, accepted in 2011-05-23,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundPre- and postconditioning describe mechanisms whereby short ischemic periods protect an organ against a longer period of ischemia. Interestingly, short ischemic periods of a limb, in itself harmless, may increase the ischemia tolerance of remote organs, e.g. the heart (remote conditioning, RC). Although several studies have shown reduced biomarker release by RC, a reduction of complications and improvement of patient outcome still has to be demonstrated. Atrial fibrillation (AF) is one of the most common complications after coronary artery bypass graft surgery (CABG), affecting 27-46% of patients. It is associated with increased mortality, adverse cardiovascular events, and prolonged in-hospital stay. We hypothesize that remote ischemic pre- and/or post-conditioning reduce the incidence of AF following CABG, and improve patient outcome.Methods/designThis study is a randomized, controlled, patient and investigator blinded multicenter trial. Elective CABG patients are randomized to one of the following four groups: 1) control, 2) remote ischemic preconditioning, 3) remote ischemic postconditioning, or 4) remote ischemic pre- and postconditioning. Remote conditioning is applied at the arm by 3 cycles of 5 minutes of ischemia and reperfusion. Primary endpoint is the incidence AF in the first 72 hours after surgery, detected using a Holter-monitor. Secondary endpoints include length-of-stay on the intensive care unit and in-hospital, and the occurrence of major adverse cardiovascular events at 30 days, 3 months and 1 year.Based on an expected incidence in the control group of 27%, 195 patients per group are needed to detect with 80% power a reduction by 45% following either pre- or postconditioning, while allowing for a 10% dropout and at an alpha of 0.05. With the combined intervention expected to be stronger, we need 75 patients in this group to detect a reduction in incidence of AF of 60%.DiscussionThe RICO-trial (the effect of Remote Ischemic Conditioning on atrial fibrillation and Outcome) is a randomized controlled multicenter trial, designed to investigate whether remote ischemic pre- and/or post-conditioning of the arm reduce the incidence of AF following CABG surgery.Trial registrationClinicalTrials.gov under NCT01107184.

【 授权许可】

Unknown   
© Brevoord et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.