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

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%.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.ClinicalTrials.gov under NCT01107184.It has been demonstrated previously that an organ can develop tolerance against ischemic stress by different interventions. In experimental studies, short periods (e.g., 3-5 minutes) of myocardial ischemia before the sustained ischemic period significantly reduced infarct size (early and late preconditioning) [1-3]. In addition, there is a significant amount of tissue that is damaged during early reperfusion, and it has been shown that staged reperfusion or short periods of ischemia (seconds to minutes) at the start of reperfusion, limits tissue damage (postconditioning) [4-6].Besides periods of ischemia, several drug