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The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC‐GTN Study
Authors:Ashraf Hamarneh MBChB  MRCP  Vivek Sivaraman MBChB  MRCP  Heerajnarain Bulluck MBChB  MRCP  Hilary Shanahan MB BCh BAO NUI FCARCSI  Bonnie Kyle BSc MBChB FRCA  Manish Ramlall MBChB  MRCP  Robin Chung MBChB  MRCP  Claire Jarvis BSc  Maria Xenou BSc  MSc  Cono Ariti MSc  Roger Cordery MB BS  FRCA  Derek M. Yellon PhD  DSc   FRCP  Derek J. Hausenloy MBChB  PhD
Affiliation:1. The Hatter Cardiovascular Institute University College London, London, United Kingdom;2. The Heart Hospital, London, United Kingdom;3. Nuffield Trust, London, United Kingdom;4. The National Institute of Health Research, University College London Hospitals Biomedical Research Centre, London, United Kingdom;5. National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore;6. Cardiovascular and Metabolic Disorders Program, Duke‐National University of Singapore, Singapore
Abstract:Remote ischemic conditioning (RIC) using transient limb ischemia/reperfusion has been reported to reduce perioperative myocardial injury in patients undergoing coronary artery bypass grafting and/or valve surgery. The role of intravenous glyceryl trinitrate (GTN) therapy administered during cardiac surgery as a cardioprotective agent and whether it interferes with RIC cardioprotection is not clear and is investigated in the ERIC‐GTN trial ( http://www.clinicaltrials.gov : NCT01864252). The ERIC‐GTN trial is a single‐site, double‐blind, randomized, placebo‐controlled study. Consenting adult patients (age > 18 years) undergoing elective coronary artery bypass grafting ± valve surgery with blood cardioplegia will be eligible for inclusion. Two hundred sixty patients will be randomized to 1 of 4 treatment groups following anesthetic induction: (1) RIC alone, a RIC protocol comprising three 5‐minute cycles of simultaneous upper‐arm and thigh cuff inflation/deflation followed by an intravenous (IV) placebo infusion; (2) GTN alone, a simulated sham RIC protocol followed by an IV GTN infusion; (3) RIC + GTN, a RIC protocol followed by an IV GTN infusion; and (4) neither RIC nor GTN, a sham RIC protocol followed by IV placebo infusion. The primary endpoint will be perioperative myocardial injury as quantified by the 72‐hour area‐under‐the‐curve serum high‐sensitivity troponin T. The ERIC‐GTN trial will determine whether intraoperative GTN therapy is cardioprotective during cardiac surgery and whether it affects RIC cardioprotection.
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