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老年患者非心脏手术后术前衰弱与心肌损伤的关系:一项前瞻性、多中心、真实世界观察性、队列研究的研究方案。

Association between preoperative frailty and myocardial injury after noncardiac surgery in geriatric patients: study protocol for a prospective, multicentre, real-world observational, cohort trial.

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Medicine, Jinan, 250014, China.

Department of Anesthesiology, Shandong Public Health Clinical Center, Shandong University, Shandong, 250013, China.

出版信息

BMC Geriatr. 2024 Mar 19;24(1):271. doi: 10.1186/s12877-024-04847-z.

Abstract

INTRODUCTION

Frailty has become a worldwide health burden that has a large influence on public health and clinical practice. The incidence of frailty is anticipated to increase as the ageing population increases. Myocardial injury after noncardiac surgery (MINS) is associated with short-term and long-term mortality. However, the incidence of MINS in frail geriatric patients is unknown.

METHODS AND ANALYSIS

This prospective, multicentre, real-world observational cohort study will be conducted at 18 designated centres in China from January 2023 to December 2024, with an anticipated sample size of 856 patients aged 65 years and older who are scheduled to undergo noncardiac surgery. The primary outcome will be the incidence of MINS. MINS is defined as a fourth-generation plasma cardiac troponin T (cTnT) concentration ≥ 0.03 ng/mL exhibited at least once within 30 days after surgery, with or without symptoms of myocardial ischaemia. All data will be collected via electronic data acquisition.

DISCUSSION

This study will explore the incidence of MINS in frail patients. The characteristics, predictive factors and 30-day outcomes of MINS in frail patients will be further investigated to lay the foundation for identifying clinical interventions.

CLINICAL TRIAL REGISTRATION

https://beta.

CLINICALTRIALS

gov/study/NCT05635877 , NCT05635877.

摘要

简介

衰弱已成为全球范围内的健康负担,对公共卫生和临床实践有重大影响。随着人口老龄化的加剧,衰弱的发病率预计将会增加。非心脏手术后心肌损伤(MINS)与短期和长期死亡率相关。然而,衰弱的老年患者发生 MINS 的情况尚不清楚。

方法和分析

这项前瞻性、多中心、真实世界观察性队列研究将于 2023 年 1 月至 2024 年 12 月在中国的 18 个指定中心进行,预计纳入 856 名年龄在 65 岁及以上、计划接受非心脏手术的患者。主要结局为 MINS 的发生率。MINS 定义为术后 30 天内至少出现一次第四代血浆心肌肌钙蛋白 T(cTnT)浓度≥0.03ng/ml,无论是否有心肌缺血症状。所有数据将通过电子数据采集收集。

讨论

本研究将探讨衰弱患者中 MINS 的发生率。还将进一步研究衰弱患者中 MINS 的特征、预测因素和 30 天结局,为确定临床干预措施奠定基础。

临床试验注册

https://beta.

临床试验

NCT05635877,NCT05635877。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a56c/10953137/a33eb05789f0/12877_2024_4847_Fig1_HTML.jpg

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