研究远程缺血预处理对接受体外循环下单纯冠状动脉旁路移植术或主动脉瓣置换术患者应激及损伤相关信号生物标志物的影响：一项随机对照试验的研究方案
Investigating the effect of remote ischaemic preconditioning on biomarkers of stress and injury-related signalling in patients having isolated coronary artery bypass grafting or aortic valve replacement using cardiopulmonary bypass: study protocol for a randomized controlled trial.
作者信息
Fiorentino Francesca, Angelini Gianni D, Suleiman M-Saadeh, Rahman Alima, Anderson Jon, Bryan Alan J, Culliford Lucy A, Moscarelli Marco, Punjabi Prakash P, Reeves Barnaby C
机构信息
National Heart and Lung Institute, Cardiothoracic Surgery Department, Imperial College London, Du Cane Road, W12 0NN, London, UK.
Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Marlborough Street, BS2 8HW, Bristol, UK.
出版信息
Trials. 2015 Apr 23;16:181. doi: 10.1186/s13063-015-0696-z.
BACKGROUND
Ischaemia-reperfusion injury occurs during heart surgery that uses cardiopulmonary bypass (CPB) and cardioplegic arrest. It is hypothesised that remote ischaemic preconditioning (RIPC) protects the heart against such injury. Despite the numerous studies investigating the protective effects of RIPC, there is still uncertainty about the interpretation of the findings as well as conflicting results between studies. The objective of this trial is to investigate the cardioprotective effect of RIPC in patients having coronary artery bypass grafting (CABG) or aortic valve replacement surgery. This will be achieved by estimating the effect of the intervention in the two groups of pathologies and by investigating the signalling mechanisms that may underpin the cardioprotective effect.
METHODS/DESIGN: A two-centre randomised controlled trial will be used to investigate the effects of RIPC in two pathologies: patients having isolated CABG and those having aortic valve replacement surgery (AVR) with CPB. Participants will be randomised to RIPC or control (sham RIPC), stratified by surgical stratum. The intervention will be delivered by a research nurse. Data will be collected by a research nurse blinded to the intervention. The patient and the theatre staff are also blinded to the allocation. Markers of myocardial injury and inflammation will be measured in myocardial biopsies and in blood samples at different times.
DISCUSSION
This trial is designed to investigate whether RIPC will reduce myocardial injury and inflammation following heart surgery and whether there is a difference in effect between participants having CABG or AVR. This trial is a unique opportunity to study the mechanisms associated with RIPC using human myocardial tissue and blood, and to relate these to the extent of myocardial injury/protection.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN33084113 (25 March 2013).
背景
在使用体外循环（CPB）和心脏停搏的心脏手术过程中会发生缺血再灌注损伤。据推测，远程缺血预处理（RIPC）可保护心脏免受此类损伤。尽管有大量研究调查了RIPC的保护作用，但研究结果的解释仍存在不确定性，且各研究之间结果相互矛盾。本试验的目的是研究RIPC在接受冠状动脉旁路移植术（CABG）或主动脉瓣置换手术患者中的心脏保护作用。这将通过评估两组病变中干预措施的效果以及研究可能作为心脏保护作用基础的信号传导机制来实现。
方法/设计：一项两中心随机对照试验将用于研究RIPC在两种病变中的作用：接受单纯CABG的患者以及接受CPB下主动脉瓣置换手术（AVR）的患者。参与者将按手术层分层随机分为RIPC组或对照组（假RIPC组）。干预措施将由一名研究护士实施。数据将由一名对干预措施不知情的研究护士收集。患者和手术室工作人员也对分配情况不知情。将在不同时间点测量心肌活检组织和血液样本中的心肌损伤和炎症标志物。
讨论
本试验旨在研究RIPC是否会减轻心脏手术后的心肌损伤和炎症，以及CABG或AVR参与者之间的效果是否存在差异。本试验是一个独特的机会，可利用人体心肌组织和血液研究与RIPC相关的机制，并将这些机制与心肌损伤/保护程度联系起来。
试验注册
Current Controlled Trials ISRCTN33084113（2013年3月25日）。
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