Abstract
BackgroundNeurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life. The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population. Remote ischemic preconditioning (RIPC) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion. This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena, by employing magnetic resonance imaging (MRI) and neurocognitive testing.MethodsPatients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study. Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure. The RIPC will be induced by inflation of a blood pressure cuff to 200 mmHg for 5 minutes, followed by a 5-minute reperfusion period. Three sequences of interchanging cuff inflations and deflations will be employed. Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day 7. Paired pre- and postoperative neurocognitive and neuroimaging data will then be compared. The primary composite outcome measure will consist of new ischemic lesions on brain MRI, postprocedural impairment in brain connectivity on resting-state functional MRI (rs-fMRI), and significant new declines in neurocognitive performance. The secondary endpoint measures will be the individual components of the primary endpoint measures, expressed as continuous variables, troponin T release on postoperative day 1 and the incidence of major adverse cardiovascular events at 3 months postoperatively. Major adverse cardiovascular events, including accumulating cardiovascular mortality, stroke, nonfatal myocardial infarction, and rehospitalization for ischemia, will form a composite endpoint measure.DiscussionThis trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response. Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting, it could impact on the current standard of care.Trial registrationClinicalTrials.gov NCT02177981.
Highlights
Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life
Thielmann et al [9] recently showed that Remote ischemic preconditioning (RIPC) induced by upper limb ischemia in patients undergoing elective coronary artery bypass grafting led to a reduction in troponin T release, which mirrored an observed reduction in mortality
In contrast with ischemic preconditioning, which is essentially restricted to the experimental arena, RIPC has the capacity for translation into the clinical domain [9]; it induces ischemic tolerance in distant organs by provoking ischemia in tissues that are both accessible and resistant to noxious stimuli
Summary
Study population The study is designed as a single-center, prospective, randomized, double-blind controlled trial (Figure 1). Inclusion criteria Adult patients (18 to 80 years) undergoing primary coronary artery bypass grafting with the use of cardiopulmonary bypass Preoperative exclusion criteria Emergent coronary artery bypass grafting Recent acute myocardial infarction History of stroke or transitory ischemic attack Structural brain abnormalities Carotid artery disease Valve surgery Left ventricular ejection fraction
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
