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中国血管性认知障碍预测、预防及个体化项目(P3):一项全国多中心前瞻性注册研究的研究设计及中期基线患者特征

Predictive, preventive and personalized project of vascular cognitive impairment in China (P3): Study design and interim baseline patient characteristics of a Nationwide multicenter prospective registry.

作者信息

Wang Linlin, Jiang Jiwei, Wang Yanli, Liu Gaifen, Li Wenyi, Ren Qiwei, Jiang Shirui, Zhao Min, Zhang Huiying, Jiang Tianlin, Yang Shiyi, Cui Mei, Dong Qiang, Xu Jun

机构信息

Department of Neurology, Beijing Tiantan Hospital Capital Medical University Beijing China.

National Clinical Research Center for Neurological Diseases Beijing China.

出版信息

Aging Med (Milton). 2024 Dec 23;7(6):744-753. doi: 10.1002/agm2.12377. eCollection 2024 Dec.

Abstract

OBJECTIVES

To outline the design of the P3 study and serve as a summary of the interim baseline patient characteristics.

METHODS

P3 study is a multicenter, prospective cohort study targeting 1000 acute ischemic stroke (AIS) and cerebral small vessel disease (CSVD) patients with a 2-year follow-up from 80 participating hospitals across China. Comprehensive multimodal imaging, neuropsychological tests, and biological samples were collected prospectively on admission and follow-up visits. Patients were interviewed face to face for 2 years and followed up.

RESULTS

Until 30 December 2023, 642 patients were enrolled from 67 centers. In the AIS cohort, 219 patients (72.5%) were diagnosed with acute post-stroke cognitive impairment (PSCI). Compared to those without PSCI, the acute PSCI group exhibited significantly lower levels of education and a history of stroke (all  < 0.05). In the CSVD cohort, 53 patients (41.4%) were diagnosed with cognitive impairment. Compared to those with normal cognitive function, the impaired cognitive function group had a significantly higher prevalence of hypertension and diabetes history (all  < 0.05). All 642 patients completed 20 tests, as well as clinical information and blood sample collection. Nearly 95% of the patients underwent structural MRI and ASL, and 60% of patients completed fMRI and DKI or DTI.

CONCLUSIONS

P3 study aims to establish a comprehensive spatiotemporal profile of VCI. Through multidimensional analysis of clinical information, radiomics, proteomics, metabolomics, microbiomics, and genetics, provide a more comprehensive understanding of VCI trajectories and individual variability, enhancing early detection and prognosis management.

摘要

目的

概述P3研究的设计,并总结中期基线患者特征。

方法

P3研究是一项多中心前瞻性队列研究,目标是纳入1000例急性缺血性卒中(AIS)和脑小血管病(CSVD)患者,来自中国80家参与研究的医院,进行为期2年的随访。前瞻性地在入院时和随访时收集综合多模态影像学、神经心理学测试和生物样本。对患者进行为期2年的面对面访谈并随访。

结果

截至2023年12月30日,从67个中心纳入了642例患者。在AIS队列中,219例患者(72.5%)被诊断为急性卒中后认知障碍(PSCI)。与无PSCI的患者相比,急性PSCI组的教育水平和卒中病史显著更低(均P<0.05)。在CSVD队列中,53例患者(41.4%)被诊断为认知障碍。与认知功能正常的患者相比,认知功能受损组的高血压和糖尿病病史患病率显著更高(均P<0.05)。所有642例患者均完成了20项检测以及临床信息和血样采集。近95%的患者接受了结构MRI和ASL检查,60%的患者完成了fMRI和DKI或DTI检查。

结论

P3研究旨在建立VCI的全面时空概况。通过对临床信息、放射组学、蛋白质组学、代谢组学、微生物组学和遗传学的多维度分析,更全面地了解VCI轨迹和个体变异性,加强早期检测和预后管理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/daa1/11702399/fb73917ad556/AGM2-7-744-g003.jpg

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