Open Access Highly Accessed Study protocol

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

Daniel Brevoord1, Markus W Hollmann1, Stefan G De Hert1, Eric HPA van Dongen2, Bram GADH Heijnen2, Anton de Bruin2, Noortje Tolenaar2, Wolfgang S Schlack1, Nina C Weber1, Marcel GW Dijkgraaf3, Joris R de Groot4, Bas AJM de Mol5, Antoine HG Driessen5, Mona Momeni6, Patrick Wouters7, Stefaan Bouchez7, Jan Hofland8, Christan Lüthen8, Tanja A Meijer-Treschan9, Benedikt H Pannen9 and Benedikt Preckel1*

Author Affiliations

1 Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Academic Medical Centre Amsterdam, The Netherlands

2 Department of Anaesthesiology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands

3 Clinical Research Unit, Academic Medical Centre Amsterdam, The Netherlands

4 Department of Cardiology, Academic Medical Centre Amsterdam, The Netherlands

5 Department of Cardiothoracic Surgery, Academic Medical Centre Amsterdam, The Netherlands

6 Department of Anaesthesiology, UCL Brussels, Belgium

7 Department of Anaesthesiology, UZ Gent, Belgium

8 Department of Anaesthesiology, Erasmus Medical Centre Rotterdam, The Netherlands

9 Department of Anaesthesiology and Intensive Care, University Hospital Düsseldorf, Germany

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BMC Anesthesiology 2011, 11:11  doi:10.1186/1471-2253-11-11

Published: 23 May 2011

Abstract

Background

Pre- 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/design

This 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%.

Discussion

The 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 registration

ClinicalTrials.gov under NCT01107184.