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

Clin Cardiol. 2015 Nov;38(11):641-6. doi: 10.1002/clc.22445. Epub 2015 Sep 28.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Biomarkers / blood
  • Clinical Protocols
  • Coronary Artery Bypass / adverse effects*
  • Double-Blind Method
  • Female
  • Humans
  • Infusions, Intravenous
  • Ischemic Preconditioning / adverse effects
  • Ischemic Preconditioning / methods*
  • London
  • Male
  • Middle Aged
  • Myocardial Reperfusion Injury / blood
  • Myocardial Reperfusion Injury / diagnosis
  • Myocardial Reperfusion Injury / etiology
  • Myocardial Reperfusion Injury / prevention & control*
  • Nitroglycerin / administration & dosage*
  • Nitroglycerin / adverse effects
  • Regional Blood Flow
  • Research Design
  • Thigh / blood supply*
  • Time Factors
  • Treatment Outcome
  • Troponin T / blood
  • Upper Extremity / blood supply*
  • Vasodilator Agents / administration & dosage*
  • Vasodilator Agents / adverse effects

Substances

  • Biomarkers
  • Troponin T
  • Vasodilator Agents
  • Nitroglycerin

Associated data

  • ClinicalTrials.gov/NCT01864252