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中风后痴呆的决定因素(DEDEMAS)研究:方案与试点数据。

The Determinants of Dementia After Stroke (DEDEMAS) Study: protocol and pilot data.

作者信息

Wollenweber Frank A, Zietemann Vera, Rominger Axel, Opherk Christian, Bayer-Karpinska Anna, Gschwendtner Andreas, Coloma Andrews Lisa, Bürger Katharina, Duering Marco, Dichgans Martin

机构信息

Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany.

出版信息

Int J Stroke. 2014 Apr;9(3):387-92. doi: 10.1111/ijs.12092. Epub 2013 Jul 9.

DOI:10.1111/ijs.12092
PMID:23834337
Abstract

RATIONALE

About 20% of stroke patients develop dementia within a few months after their event, but the determinants and mechanisms of poststroke dementia are insufficiently understood.

AIMS

To identify and characterize the determinants of cognitive impairment poststroke.

DESIGN

Observational prospective study in patients with acute stroke and no prior dementia. Six hundred subjects will be characterized by detailed interview, standardized clinical examinations, biometric measures (intima-media thickness, waist-hip ratio, and ankle-brachial index), multimodal imaging (magnetic resonance imaging, fluorodeoxyglucose-positron emission tomography (FDG-PET), amyloid-positron emission tomography (amyloid-PET), and retinal imaging), analysis of biomarkers derived from blood and cerebrospinal fluid, and detailed cognitive testing at repeat time points. Patients will be followed for five-years with a total of five personal visits and three telephone interviews.

STUDY OUTCOMES

Primary end-point is the occurrence of poststroke dementia. Secondary end-points include poststroke cognitive impairment-no dementia, stroke recurrence, and death. Predictive factors for poststroke dementia will be identified by multiple Cox proportional-hazards model.

RESULTS

Baseline characteristics of the first 71 patients (study inclusion between May 2011 and August 2012) are as follows: median age, 70 years (interquartile range, 65-75); female gender, 25 (35%); median National Institutes of Health Stroke Scale at admission, 2 (1-4); and etiological stroke subtypes according to TOAST classification, 15% large artery disease, 18% small vessel disease, 35% cardioembolic, and 32% undetermined or multiple competing etiologies.

DISCUSSION

This study will provide insights into the mechanisms of poststroke dementia and hold the potential to identify novel diagnostic markers and targets for preventive therapies. The study is registered at http://www.clinicaltrials.gov (NCT01334749) and will be extended as a multicenter study starting 2013.

摘要

理论依据

约20%的中风患者在发病后的几个月内会患上痴呆症,但中风后痴呆症的决定因素和机制尚未得到充分了解。

目的

识别并描述中风后认知障碍的决定因素。

设计

对急性中风且既往无痴呆症的患者进行观察性前瞻性研究。600名受试者将通过详细访谈、标准化临床检查、生物测量指标(内膜中层厚度、腰臀比和踝臂指数)、多模态成像(磁共振成像、氟脱氧葡萄糖正电子发射断层扫描(FDG-PET)、淀粉样蛋白正电子发射断层扫描(淀粉样蛋白-PET)和视网膜成像)、血液和脑脊液生物标志物分析以及在重复时间点进行详细的认知测试来进行特征描述。患者将被随访5年,共进行5次个人访视和3次电话访谈。

研究结果

前71名患者(2011年5月至2012年8月纳入研究)的基线特征如下:年龄中位数为70岁(四分位间距为65 - 75岁);女性25名(35%);入院时美国国立卫生研究院卒中量表中位数为2(1 - 4);根据TOAST分类,病因性中风亚型为:大动脉疾病15%,小血管疾病18%,心源性栓塞35%,不明或多种病因并存32%。

讨论

本研究将深入了解中风后痴呆症的机制,并有可能识别出新的诊断标志物和预防性治疗靶点。该研究已在http://www.clinicaltrials.gov注册(NCT01334749),并将于2013年开始扩展为多中心研究。

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