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远程缺血预处理和硝酸甘油对心脏搭桥手术患者围手术期心肌损伤的影响:ERIC-GTN研究的原理与设计

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.

作者信息

Hamarneh Ashraf, Sivaraman Vivek, Bulluck Heerajnarain, Shanahan Hilary, Kyle Bonnie, Ramlall Manish, Chung Robin, Jarvis Claire, Xenou Maria, Ariti Cono, Cordery Roger, Yellon Derek M, Hausenloy Derek J

机构信息

The Hatter Cardiovascular Institute University College London, London, United Kingdom.

The Heart Hospital, London, United Kingdom.

出版信息

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.

摘要

据报道,采用短暂肢体缺血/再灌注的远程缺血预处理(RIC)可减少接受冠状动脉搭桥术和/或瓣膜手术患者的围手术期心肌损伤。心脏手术期间静脉注射硝酸甘油(GTN)作为一种心脏保护剂的作用以及它是否会干扰RIC的心脏保护作用尚不清楚,ERIC-GTN试验(http://www.clinicaltrials.gov: NCT01864252)对此进行了研究。ERIC-GTN试验是一项单中心、双盲、随机、安慰剂对照研究。同意参与的成年患者(年龄>18岁),接受择期冠状动脉搭桥术±瓣膜手术并采用血液停搏液,将符合纳入条件。260名患者将在麻醉诱导后随机分为4个治疗组中的1组:(1)单独RIC组,一种RIC方案,包括三个5分钟的循环,同时进行上臂和大腿袖带充气/放气,随后静脉注射(IV)安慰剂;(2)单独GTN组,一种模拟假RIC方案,随后静脉注射GTN;(3)RIC + GTN组,一种RIC方案,随后静脉注射GTN;(4)既不进行RIC也不进行GTN组,一种假RIC方案,随后静脉注射安慰剂。主要终点将是围手术期心肌损伤,通过72小时曲线下面积血清高敏肌钙蛋白T进行量化。ERIC-GTN试验将确定术中GTN治疗在心脏手术期间是否具有心脏保护作用以及它是否会影响RIC的心脏保护作用。

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