Observational Study of the Association between TCM Zheng and Types of Coronary Artery Stenosis: Protocol of a Multicenter Case Series Study

Abstract

Background. Coronary artery stenosis is the major pathological change of coronary heart disease (CHD). Within the framework of traditional Chinese medicine (TCM) theory, some kinds of TCM Zheng could exist in patients with CHD; accordingly, TCM practitioners could provide appropriate TCM therapy. However, little is known about the association between TCM Zheng and types of coronary artery stenosis. Such knowledge could help improve the accuracy and effectiveness of efforts to combine CHD treatment with TCM therapy. Therefore, the aim of this study is to determine the association between TCM Zheng and types of coronary artery stenosis. Methods and Design. This is a multicenter, large sample, case series study in 4 tertiary A hospitals from 3 provinces in China. A total of 3,000 eligible patients diagnosed with atherosclerosis or CHD and selected to undergo coronary angiography (CAG) will be enrolled in this study. We will use electronic case report forms (eCRF) to collect information, including baseline characteristics, TCM symptoms, CAG results, and GRACE scores according to standard operating procedures (SOP). Data will be analyzed by SPSS 20.0. Ethics. This study is approved by the Ethics Committee of Guang'anmen Hospital of the China Academy of Chinese Medical Sciences (no. 2017-058-KY-01) and is registered with chictr.org (registration number ChiCTR-ROC-17013221).