Boomsma Jooske Marije Funke, Exalto Lieza Geertje, Barkhof Frederik, van den Berg Esther, de Bresser Jeroen, Heinen Rutger, Koek Huiberdina Lena, Prins Niels Daniël, Scheltens Philip, Weinstein Henry Chanoch, van der Flier Wiesje Maria, Biessels Geert Jan
Department of Neurology, Neurosurgery and Neuropsychology, Brain Centre Rudolf Magnus Institute, University Medical Centre Utrecht, Utrecht, Netherlands.
Onze Lieve Vrouwe Gasthuis (OLVG) West, Department of Neurology, Amsterdam, Netherlands.
JMIR Res Protoc. 2017 Apr 19;6(4):e60. doi: 10.2196/resprot.6864.
Vascular Cognitive Impairment (VCI) refers to cognitive dysfunction due to vascular brain injury, as a single cause or in combination with other, often neurodegenerative, etiologies. VCI is a broad construct that captures a heterogeneous patient population both in terms of cognitive and noncognitive symptoms and in terms of etiology and prognosis. This provides a challenge when applying this construct in clinical practice.
This paper presents the rationale and design of the TRACE-VCI study, which investigates the clinical features and prognosis of VCI in a memory clinic setting.
The TRACE-VCI project is an observational, prospective cohort study of 861 consecutive memory clinic patients with possible VCI. Between 2009 and 2013, patients were recruited through the Amsterdam Dementia Cohort of the VU University Medical Centre (VUMC) (N=665) and the outpatient memory clinic and VCI cohort of the University Medical Centre Utrecht (UMCU) (N=196). We included all patients attending the clinics with magnetic resonance imaging (MRI) evidence of vascular brain injury. Patients with a primary etiology other than vascular brain injury or neurodegeneration were excluded. Patients underwent an extensive 1-day memory clinic evaluation including an interview, physical and neurological examination, assessment of biomarkers (including those for Alzheimer-type pathologies), extensive neuropsychological testing, and an MRI scan of the brain. For prognostic analyses, the composite primary outcome measure was defined as accelerated cognitive decline (change of clinical dementia rating ≥1 or institutionalization) or (recurrent) major vascular events or death over the course of 2 years.
The mean age at baseline was 67.7 (SD 8.5) years and 46.3% of patients (399/861) were female. At baseline, the median Clinical Dementia Rating was 0.5 (interquartile range [IQR] 0.5-1.0) and the median Mini-Mental State Examination score was 25 (IQR 22-28). The clinical diagnosis at baseline was dementia in 52.4% of patients (451/861), mild cognitive impairment in 24.6% (212/861), and no objective cognitive impairment in the remaining 23.0% (198/861).
The TRACE-VCI study represents a large cohort of well-characterized patients with VCI in a memory clinic setting. Data processing and collection for follow-up are currently being completed. The TRACE-VCI study will provide insight into the clinical features of memory clinic patients that meet VCI criteria and establish key prognostic factors for further cognitive decline and (recurrent) major vascular events.
血管性认知障碍（VCI）是指由脑血管损伤导致的认知功能障碍，其可为单一病因，也可与其他病因（通常为神经退行性病因）共同作用。VCI是一个宽泛的概念，涵盖了认知和非认知症状、病因及预后方面均存在异质性的患者群体。这在临床实践中应用该概念时带来了挑战。
本文介绍TRACE-VCI研究的基本原理和设计，该研究在记忆门诊环境中调查VCI的临床特征和预后。
TRACE-VCI项目是一项对861例连续的可能患有VCI的记忆门诊患者进行的观察性前瞻性队列研究。2009年至2013年期间，通过阿姆斯特丹自由大学医学中心（VU大学医学中心）的阿姆斯特丹痴呆队列（N = 665）以及乌得勒支大学医学中心（UMCU）的门诊记忆门诊和VCI队列招募患者（N = 196）。我们纳入了所有经磁共振成像（MRI）证实存在脑血管损伤证据的门诊患者。排除原发性病因不是脑血管损伤或神经退行性病变的患者。患者接受了为期1天的全面记忆门诊评估，包括访谈、体格和神经学检查、生物标志物评估（包括阿尔茨海默病型病理相关标志物）、广泛的神经心理学测试以及脑部MRI扫描。对于预后分析，复合主要结局指标定义为2年内认知加速衰退（临床痴呆评定量表变化≥1或入住机构）或（复发性）重大血管事件或死亡。
基线时的平均年龄为67.7（标准差8.5）岁，46.3%的患者（399/861）为女性。基线时，临床痴呆评定量表的中位数为0.5（四分位间距[IQR] 0.5 - 1.0），简易精神状态检查表得分的中位数为25（IQR 22 - 28）。基线时的临床诊断为痴呆的患者占52.4%（451/861），轻度认知障碍的患者占24.6%（212/861），其余23.0%（198/861）无客观认知障碍。
TRACE-VCI研究代表了记忆门诊环境中一大群特征明确的VCI患者。目前正在完成随访的数据处理和收集工作。TRACE-VCI研究将深入了解符合VCI标准的记忆门诊患者的临床特征，并确定进一步认知衰退和（复发性）重大血管事件的关键预后因素。
