title: Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial).
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
  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%.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov under NCT01107184.
authors: Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L,E,I,C,A,), Academic Medical Centre Amsterdam, The Netherlands. b.preckel@amc.uva.nl.
authors: Daniel
authors: D
authors: Brevoord
authors: Markus W
authors: MW
authors: Hollmann
authors: Stefan G
authors: SG
authors: De Hert
authors: Eric Hpa
authors: EH
authors: van Dongen
authors: Bram Gadh
authors: BG
authors: Heijnen
authors: Anton
authors: A
authors: de Bruin
authors: Noortje
authors: N
authors: Tolenaar
authors: Wolfgang S
authors: WS
authors: Schlack
authors: Nina C
authors: NC
authors: Weber
authors: Marcel Gw
authors: MG
authors: Dijkgraaf
authors: Joris R
authors: JR
authors: de Groot
authors: Bas Ajm
authors: BA
authors: de Mol
authors: Antoine Hg
authors: AH
authors: Driessen
authors: Mona
authors: M
authors: Momeni
authors: Patrick
authors: P
authors: Wouters
authors: Stefaan
authors: S
authors: Bouchez
authors: Jan
authors: J
authors: Hofland
authors: Christan
authors: C
authors: Lüthen
authors: Tanja A
authors: TA
authors: Meijer-Treschan
authors: Benedikt H
authors: BH
authors: Pannen
authors: Benedikt
authors: B
authors: Preckel
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