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全生命周期综合准确性心脏瓣膜病流行病学队列研究(iWAVE):一项前瞻性队列研究方案

Integrated Whole-Life Cycle Accuracy Valvular Heart Disease Epidemiology Cohort Study (iWAVE): protocol for a prospective cohort study.

作者信息

Liu Xiang, Wang Yuqiang, Cao Tingqian, Jun Shi, Liu Lulu, Zhou Yongzhao, Guo Yingqiang

机构信息

Department of Cardiovascular Surgery and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, People's Republic of China.

Information Technology Center, West China Hospital, Sichuan University, Chengdu, China.

出版信息

BMJ Open. 2024 Dec 3;14(12):e090075. doi: 10.1136/bmjopen-2024-090075.

DOI:10.1136/bmjopen-2024-090075
PMID:39627131
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624791/
Abstract

INTRODUCTION

Despite the rapid advancements in cardiovascular surgery in China, the prevalence of valvular heart disease (VHD) continues to rise, particularly among the elderly population. In the resource-constrained western regions, the lack of an integrated care management system significantly contributes to the burden of cardiovascular disease. Consequently, a comprehensive cohort data platform that encompasses the entire lifespan of patients with VHD is essential. This prospective cohort study aims to facilitate the examination of risk factor screening, disease progression, diagnostic and treatment strategies, and the long-term functional recovery trajectories of patients following valve surgery.

METHODS AND ANALYSIS

The Integrated Whole-Life Cycle Accuracy Valvular Heart Disease Epidemiology Cohort Study is a prospective cohort study that plans to enrol approximately 10 000 participants, including both patients with VHD and members of the general population, by 2028. Led by the West China Hospital of Sichuan University, it will be conducted in collaboration with 15 medical consortiums and their affiliated community hospitals. This study seeks to assess the disease trajectory of VHD, as well as the risk factors and protective measures that influence its progression and prognosis. This study will collect and analyse basic demographic information, peripheral blood and tissue samples, long-term functional follow-up data, and patient-reported outcome questionnaires. Additionally, electronic health records will be used to document patients with VHD undergoing surgical interventions, along with lifetime endpoint events for the valve clinical study.

ETHICS AND DISSEMINATION

The study protocol was approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (No. 20232422). All participants will be required to provide written informed consent. The study findings will be disseminated via publications in peer-reviewed journals and presentations at scientific conferences.

摘要

引言

尽管中国心血管外科手术取得了快速进展,但瓣膜性心脏病(VHD)的患病率仍在上升,尤其是在老年人群中。在资源有限的西部地区,缺乏综合护理管理系统显著加重了心血管疾病的负担。因此,一个涵盖VHD患者整个生命周期的综合队列数据平台至关重要。这项前瞻性队列研究旨在促进对风险因素筛查、疾病进展、诊断和治疗策略以及瓣膜手术后患者长期功能恢复轨迹的研究。

方法与分析

全生命周期精准瓣膜性心脏病流行病学综合队列研究是一项前瞻性队列研究,计划到2028年招募约10000名参与者,包括VHD患者和普通人群成员。该研究由四川大学华西医院牵头,将与15个医疗联合体及其附属社区医院合作开展。本研究旨在评估VHD的疾病轨迹,以及影响其进展和预后的风险因素和保护措施。本研究将收集和分析基本人口统计学信息、外周血和组织样本、长期功能随访数据以及患者报告结局问卷。此外,电子健康记录将用于记录接受手术干预的VHD患者,以及瓣膜临床研究的终身终点事件。

伦理与传播

本研究方案已获得四川大学华西医院生物医学研究伦理委员会批准(编号:20232422)。所有参与者都将被要求提供书面知情同意书。研究结果将通过在同行评审期刊上发表以及在科学会议上进行报告的方式进行传播。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/5626714ffdfb/bmjopen-14-12-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/833d2ff85857/bmjopen-14-12-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/5626714ffdfb/bmjopen-14-12-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/833d2ff85857/bmjopen-14-12-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/f82f3282580d/bmjopen-14-12-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f338/11624791/b08c3b57748e/bmjopen-14-12-g003.jpg
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