A clinical trial for computed tomography myocardial perfusion based non-invasive index of microcirculatory resistance (MPBIMR): rationale and trial design

Beibei Gao; Darong Zhu; Jianchang Xie; Bokai Wu; Peng Xu; Jia Liu; Xiaoshan Tong; Rongliang Chen; Lijun Zhu; Liang Zhou; Yufeng Qian; Xianhua Ye; Jianmin Yang; Shasha Meng; Junjie Gu; Guoxin Tong; Jinyu Huang

A clinical trial for computed tomography myocardial perfusion based non-invasive index of microcirculatory resistance (MPBIMR): rationale and trial design

Am J Transl Res. 2022 Aug 15;14(8):5552-5562. eCollection 2022.

Authors

Beibei Gao¹, Darong Zhu², Jianchang Xie¹, Bokai Wu³, Peng Xu¹, Jia Liu³, Xiaoshan Tong^{1

4}, Rongliang Chen³, Lijun Zhu¹, Liang Zhou¹, Yufeng Qian¹, Xianhua Ye^{1

4}, Jianmin Yang¹, Shasha Meng^{1

4}, Junjie Gu^{1

4}, Guoxin Tong¹, Jinyu Huang¹

Affiliations

¹ Department of Cardiology, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine Hangzhou 310000, Zhejiang Province, China.
² Department of Radiology, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine Hangzhou 310000, Zhejiang Province, China.
³ Institute of Advanced Computing and Digital Engineering, Institutes of Advanced Technology, Chinese Academy of Sciences Shenzhen 518000, Guangdong Province, China.
⁴ Department of Cardiac Catheterization Room, Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine Hangzhou 310000, Zhejiang Province, China.

PMID: 36105013
PMCID: PMC9452323

Abstract

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.

Keywords: Index of microcirculatory resistance; cardiovascular imaging; coronary intervention; coronary microvascular disease; hydrodynamics.