基于计算机断层扫描心肌灌注的微循环阻力无创指数（MPBIMR）的临床试验：原理与试验设计
A clinical trial for computed tomography myocardial perfusion based non-invasive index of microcirculatory resistance (MPBIMR): rationale and trial design.
作者信息
Gao Beibei, Zhu Darong, Xie Jianchang, Wu Bokai, Xu Peng, Liu Jia, Tong Xiaoshan, Chen Rongliang, Zhu Lijun, Zhou Liang, Qian Yufeng, Ye Xianhua, Yang Jianmin, Meng Shasha, Gu Junjie, Tong Guoxin, Huang Jinyu
机构信息
Department of Cardiology, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine Hangzhou 310000, Zhejiang Province, China.
Department of Radiology, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine Hangzhou 310000, Zhejiang Province, China.
出版信息
Am J Transl Res. 2022 Aug 15;14(8):5552-5562. eCollection 2022.
INTRODUCTION
Accurate and rapid assessment of the coronary microcirculation has become an important medical challenge. However, reliable and non-invasive quantitative methods to diagnose coronary microvascular disease (CMVD), select treatments for coronary artery disease (CAD), and therefore improve coronary microcirculation are lacking. Current detection methods have limitations. Therefore, we will assess whether a new detection method, the non-invasive index of microcirculatory resistance (IMR), based on computed tomography (CT) perfusion and hydrodynamics (CT-IMR), can effectively evaluate the function of coronary microvessels.
METHODS
We will conduct a multicenter, randomized, open-label study, including a Phase I single-center and Phase II multicenter trial, to assess the accuracy of the non-invasive CT-IMR coronary measurement of microcirculation function. The study will enroll 295 patients who will undergo coronary CT angiography (CCTA), dynamic CT-myocardial perfusion imaging (CT-MPI), invasive coronary angiography (ICA), and invasive IMR. This study will identify the key influencing factors when calculating myocardial microcirculation perfusion and develop an accurate three-dimensional coronary reconstruction method and a non-invasive coronary IMR calculation method based on computational fluid dynamics (CFD). This will facilitate the development of a non-invasive system to detect and measure coronary microcirculation.
CONCLUSION
The clinical trial for computed tomography myocardial perfusion based non-invasive index of microcirculatory resistance (MPBIMR) will establish the key influencing factors when calculating myocardial microcirculation perfusion and create a non-invasive CT-IMR calculation method based on CFD. This method may diagnose patients with simple coronary microvascular lesions and those with coronary microvascular lesions combined with coronary vascular lesions.
引言
准确快速地评估冠状动脉微循环已成为一项重要的医学挑战。然而，目前缺乏可靠的非侵入性定量方法来诊断冠状动脉微血管疾病（CMVD）、选择冠状动脉疾病（CAD）的治疗方案，进而改善冠状动脉微循环。当前的检测方法存在局限性。因此，我们将评估一种基于计算机断层扫描（CT）灌注和流体动力学的新检测方法——微循环阻力无创指数（IMR），即CT-IMR，能否有效评估冠状动脉微血管功能。
方法
我们将开展一项多中心、随机、开放标签研究，包括I期单中心试验和II期多中心试验，以评估非侵入性CT-IMR冠状动脉微循环功能测量的准确性。该研究将纳入295例患者，他们将接受冠状动脉CT血管造影（CCTA）、动态CT心肌灌注成像（CT-MPI）、有创冠状动脉造影（ICA）和有创IMR检查。本研究将确定计算心肌微循环灌注时的关键影响因素，并开发一种基于计算流体动力学（CFD）的准确三维冠状动脉重建方法和非侵入性冠状动脉IMR计算方法。这将有助于开发一种检测和测量冠状动脉微循环的非侵入性系统。
结论
基于计算机断层扫描心肌灌注的微循环阻力无创指数（MPBIMR）的临床试验将确定计算心肌微循环灌注时的关键影响因素，并创建一种基于CFD的非侵入性CT-IMR计算方法。该方法可能诊断单纯冠状动脉微血管病变患者以及合并冠状动脉血管病变的冠状动脉微血管病变患者。
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