左室整体纵向峰值应变值变化可对老年高危冠状动脉粥样硬化性心脏病进行早期诊断:一项单中心、诊断性临床试验方案

摘要

BACKGROUND:Previous studies have demonstrated that tissue Doppler echocardiography and two-dimensional speckle tracking echocardiography are minimally invasive imaging methods used to screen for coronary atherosclerotic heart disease.However,they are not highly sensitive and specific for patients with suspected heart disease presenting with normal ventricular wall motion or for patients with early coronary heart disease.The newly emerging three-dimensional longitudinal strain imaging technology can overcome these shortcomings and has become a relatively mature technique for quantitative assessment of myocardial function.OBJECTIVE:To investigate the early diagnosis value of left ventricular global longitudinal peak strain (LVGLPS)measured by three-dimensional longitudinal strain imaging technology for high-risk coronary atherosclerotic heart disease.METHODS:This is a single-center,open-label,diagnostic trial.Three hundred elderly patients suspected of coronary atherosclerotic heart disease receiving treatment at the Department of Ultrasound Medicine,Taihe Hospital of China from January 2013 to January 2018 are included in this study.These patients will be divided into three groups:low-risk group (n=100;≥ 70％ diameter stenosis in one or two branches of the right main coronary artery and the left circumflex artery),high-risk group (n=100;≥ 50％ diameter stenosis in the left main coronary artery or ≥ 70％ diameter stenosis in the left anterior descending branch),and control group (n=100;＜50％ diameter stenosis in the main coronary arteries and all branches).All patients will undergo conventional echocardiography followed by three-dimensional longitudinal strain imaging to measure the LVGLPS.The LVGLPS will be compared among the three groups.The primary outcome measure is the sensitivity of the LVGLPS for prediction of coronary atherosclerotic heart disease.The secondary outcome measures are:the specificity,positive predictive value,negative predictive value,positive likelihood ratio,negative likelihood ratio,and accuracy rate of the LVGLPS for prediction of coronary atherosclerotic heart disease;change in the LVGLPS;change in conventional echocardiography parameters;and change in the receiver operating characteristic curve for prediction of high-risk coronary atherosclerotic heart disease using the LVGLPS.This study will be performed in accordance with the Declaration of Helsinki.All patients have been informed of the study protocol and procedure and have provided written informed consent.This trial was approved by Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) with the approval No.2013(03) in January 2013.Participant recruitment and data collection began in January 2013 and will continue through December 2017.Outcome measure analysis will be performed and the trial will be completed in January 2018.Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals.This trial was registered with ClinicalTrial.gov (identifier:ChiCTR-DDD-17012839).DISCUSSION:The findings from this study will help to confirm that three-dimensional longitudinal strain imaging technology is highly sensitive and specific for patients with abnormal coronary arteries with suspected coronary heart disease but who present with normal ventricular wall motion.The change in the LVGLPS contributes to early diagnosis of high-risk coronary atherosclerotic heart disease in elderly patients.This helps clinicians to diagnose early coronary heart disease and take timely strategies to avoid serious cardiovascular events as much as possible.%背景:既往研究表明,组织多普勒成像技术、二维斑点追踪成像技术等可无创地检测冠状动脉粥样硬化性心脏病变,但对无室壁运动异常或冠状动脉粥样硬化性心脏病早期患者,其敏感性和特异性均不高.近年发展的三维纵向应变成像技术,可克服上述缺点,已成为目前比较成熟的一种定量评估心肌功能的新技术.而三维纵向应变成像检测的左室整体纵向峰值是预测高危冠状动脉粥样硬化性心脏病较敏感的指标.目的:观察左室整体纵向峰值应变值变化对老年高危冠状动脉粥样硬化性心脏病的早期诊断价值.方法:研究为单中心、开放性、诊断性试验.选取2013年1月至2018年1月湖北省十堰市太和医院超声科的疑似老年冠状动脉粥样硬化性心脏病患者300例,按冠状动脉造影结果分为3组,低危组100例即右冠状动脉主干、左回旋支中一两支狭窄≥70％,高危组100例即左冠状动脉主干狭窄≥50％或左前降支狭窄≥70％,对照组100例即冠状动脉主干及所有分支狭窄均＜50％.所有病例均行常规超声心动图检查后再应用三维纵向应变成像测量各组左室整体纵向峰值应变值,并比较其差异.试验的主要观察指标为左室整体纵向峰值应变值变化诊断冠状动脉粥样硬化性心脏病的敏感度.试验的次要观察指标为左室整体纵向峰值应变值变化诊断冠状动脉粥样硬化性心脏病的特异度,阳性预测值、阴性预测值、阳性似然比、阴性似然比及诊断正确率;各组左室整体纵向峰值变化;各组常规超声心动图各检测参数变化;左室整体纵向峰值预测冠状动脉粥样硬化性心脏病高危因素的ROC曲线变化.试验经湖北省十堰市太和医院伦理委员会批准.研究符合世界医学会制定的《赫尔辛基宣言》的要求.参与者本人对试验方案和过程均知情同意,并签署知情同意书.试验伦理审批[审批单位:十堰市太和医院,审批号:伦理号2013第(03)号]为2013年1月,样本及数据收集时间为2013年1月至2017年12月,结果指标分析时间及试验完成时间为2018年1月.文章结果将以科学会议报告,或在同行评议的期刊上发表传播.试验己在中国临床试验注册中心注册(注册号:ChiCTR-DDD-17012839).讨论:试验希望证实,三维纵向应变成像可发现无室壁运动异常的疑诊冠状动脉粥样硬化性心脏病患者是否存在冠状动脉异常,其敏感性和特异性均较高,左室整体纵向峰值应变值变化可对老年高危冠状动脉粥样硬化性心脏病进行早期诊断,这有助于帮助临床医师早期诊断该类冠状动脉粥样硬化性心脏病患者并及时采取措施,尽可能避免发生严重的心血管不良事件.