Association of perioperative glucose profiles assessed by continuous glucose monitoring (CGM) with prognosis in Chinese patients with non-ST-elevation acute coronary syndrome: a cohort study protocol

Author:

Shi Jie,Zhang Hongqiang,Wang Xulin,Weng Jiahao,Ding YuORCID,Wu Jiawei,Zheng Xueying,Luo SihuiORCID,Hu HaoORCID

Abstract

IntroductionNon-ST-elevation acute coronary syndrome (NSTE-ACS) remains a significant clinical concern, accounting for over 70% of acute coronary syndrome cases. One well-established risk factor for NSTE-ACS is abnormal glucose metabolism, which is associated with a poor prognosis postpercutaneous coronary intervention. Effective monitoring of blood glucose is crucial in diabetes care, as it helps identify glucose metabolic imbalances, thereby guiding therapeutic strategies and assessing treatment efficacy. Continuous glucose monitoring (CGM) provides comprehensive glucose profiles. Therefore, the study aims to use CGM to track perioperative glucose variations in NSTE-ACS patients and to determine its prognostic implications.Methods and analysisThis is a multicentre, prospective observational study in a sample of patients (aged >18 years) with NSTE-ACS. A total of 1200 eligible patients will be recruited within 1 year at 6 sites in China. The primary composite endpoint will be determined as major adverse cardiovascular events (MACE) at 3 years. MACE includes all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and target vessel revascularisation. Employing the CGM system, glucose levels will be continuously monitored throughout the perioperative phase. Prespecified cardiovascular analyses included analyses of the components of this composite and outcomes according to CGM-derived glucometrics at baseline.Ethics and disseminationThis study has received approval from the Medical Research Ethics Committee of The First Affiliated Hospital of the University of Science and Technology of China (No. 2022KY357) and will adhere to the moral, ethical and scientific principles outlined in the Declaration of Helsinki. All participants will provide written informed consent prior to any study-related procedures. Findings from the study will be shared at conferences and published in peer-reviewed scientific journals.Trial registration numberChiCT2300069663.

Funder

Research Funds of Centre for Leading Medicine and Advanced Technologies of IHM

Clinical Medical Research Transformation Project of Anhui Province

the Shannan Municipal Science and Technology Bureau Project

Major Program of Department of Education of Anhui Province

Medical Professional Delegation Aid Tibet Program of Natural Science Foundation of Tibet Autonomous Region

Publisher

BMJ

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