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脑小血管病非急性症状患者认知能力下降的发展:非急性症状性脑缺血登记研究(NASCIR)-一项前瞻性多中心观察性研究的原理和方案。

Development of cognition decline in non-acute symptomatic patients with cerebral small vessel disease: Non-Acute Symptomatic Cerebral Ischemia Registration study (NASCIR)-rationale and protocol for a prospective multicentre observational study.

机构信息

Department of Neurology, Sichuan University West China Hospital, Chengdu, Sichuan, China.

Department of Radiology, Sichuan University West China Hospital, Chengdu, Sichuan, China.

出版信息

BMJ Open. 2022 Feb 22;12(2):e050294. doi: 10.1136/bmjopen-2021-050294.

DOI:10.1136/bmjopen-2021-050294
PMID:35193901
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8867377/
Abstract

INTRODUCTION

Headaches, dizziness and memory loss of unspecific causes are the most common non-acute ischemia symptoms in the ageing population, which are often associated with cerebral small vessel disease (CSVD) imaging markers; however, there is insufficient evidence concerning their association with the development of cognitive decline. This study aims to investigate risk factors, clinical course, cerebral and retinal imaging changes, proteomics features of non-symptomatic ischaemia symptomatic patients with cognitive decline.

METHODS AND ANALYSIS

The Non-Acute Symptomatic Cerebral Ischemia Registration study is a multicentre, registry-based, prospective observational study, is designed to investigate the cognitive decline in non-acute ischaemia symptomatic patients. We will recruit 500 non-acute ischaemia symptomatic patients from four tertiary hospitals in China. For this study, non-acute ischaemia symptoms will be defined as headaches, dizziness and memory loss. Patients with headaches, dizziness or memory loss over 50 years of age will be included. Clinical features, cognitive assessment, cerebral and retinal imaging data, and a blood sample will be collected after recruitment. Patients will be followed up by structured telephone interviews at 1, 2, 3, 4, 5 years after recruitment. This study will improve our knowledge of the development of cognitive decline in non-acute ischaemia symptomatic patients and factors affecting the cognitive outcomes, which will eventually elucidate underlying pathways and mechanisms of cognitive decline in these patients and facilitate the optimisation of individualised interventions for its prevention and treatment.

ETHICS AND DISSEMINATION

Ethics approval is obtained from The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2016 (335)). We will present our findings at national and international conferences and peer-reviewed journals in stroke and neurology.

TRIAL REGISTRATION NUMBER

ChiCTR-COC-17013056.

摘要

简介

老年人常见的非急性缺血性头痛、头晕和记忆力减退是最常见的非急性缺血症状,这些症状通常与脑小血管疾病(CSVD)的影像学标志物有关;然而,关于这些症状与认知能力下降的发展之间的关联,证据不足。本研究旨在调查非急性症状性脑缺血患者认知能力下降的危险因素、临床病程、脑和视网膜影像学变化、非症状性缺血性无症状患者的蛋白质组学特征。

方法和分析

非急性症状性脑缺血登记研究是一项多中心、基于登记的前瞻性观察性研究,旨在调查非急性缺血性症状患者的认知能力下降。我们将从中国四家三级医院招募 500 名非急性缺血性症状患者。在本研究中,非急性缺血症状将定义为头痛、头晕和记忆力减退。将纳入年龄在 50 岁以上出现头痛、头晕或记忆力减退的患者。招募后将收集临床特征、认知评估、脑和视网膜影像学数据以及血样。招募后 1、2、3、4、5 年,将通过结构化电话访谈对患者进行随访。本研究将提高我们对非急性缺血性症状患者认知能力下降发展的认识以及影响认知结果的因素,最终阐明这些患者认知能力下降的潜在途径和机制,并有助于优化针对其预防和治疗的个体化干预措施。

伦理和发布

本研究已获得四川大学华西医院生物医学研究伦理委员会的伦理批准(编号:2016(335))。我们将在国内和国际卒中与神经病学会议和同行评议期刊上报告我们的研究结果。

临床试验注册编号

ChiCTR-COC-17013056。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6558/8867377/683b67ae90e5/bmjopen-2021-050294f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6558/8867377/683b67ae90e5/bmjopen-2021-050294f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6558/8867377/683b67ae90e5/bmjopen-2021-050294f01.jpg

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