基于连续血糖监测评估的围手术期血糖谱与中国非 ST 段抬高型急性冠状动脉综合征患者预后的相关性：一项队列研究方案。

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.

机构信息

Department of Endocrinology, Centre for Leading Medicine and Advanced Technologies of IHM, The First Affiliated Hospital of USTC， Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, China, University of Science and Technology of China, Hefei, Anhui, China.

Department of Cardiology, The First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, Anhui, China.

出版信息

BMJ Open. 2024 Jun 12;14(6):e079666. doi: 10.1136/bmjopen-2023-079666.

DOI:10.1136/bmjopen-2023-079666

PMID:38866564

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11177667/

Abstract

INTRODUCTION

Non-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 ANALYSIS

This 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 DISSEMINATION

This 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 NUMBER

ChiCT2300069663.

摘要

简介

非 ST 段抬高型急性冠状动脉综合征（NSTE-ACS）仍然是一个重大的临床关注点，占急性冠状动脉综合征病例的 70%以上。NSTE-ACS 的一个公认的危险因素是异常的葡萄糖代谢，这与经皮冠状动脉介入治疗后的不良预后相关。在糖尿病护理中，有效监测血糖至关重要，因为它有助于识别葡萄糖代谢失衡，从而指导治疗策略并评估治疗效果。连续血糖监测（CGM）提供全面的血糖谱。因此，本研究旨在使用 CGM 跟踪 NSTE-ACS 患者围手术期的血糖变化，并确定其预后意义。

方法和分析

这是一项在中国 6 个地点进行的多中心、前瞻性观察性研究，纳入了年龄>18 岁的 NSTE-ACS 患者样本。在 1 年内将招募 1200 名符合条件的患者。主要复合终点将在 3 年内确定为主要不良心血管事件（MACE）。MACE 包括全因死亡率、非致死性心肌梗死、非致死性卒中和靶血管血运重建。使用 CGM 系统，将在围手术期全程连续监测血糖水平。预设的心血管分析包括根据基线时 CGM 衍生的血糖指标对该复合终点的组成部分和结果进行分析。