Thingstad Pernille, Askim Torunn, Beyer Mona K, Bråthen Geir, Ellekjær Hanne, Ihle-Hansen Hege, Knapskog Anne Brita, Lydersen Stian, Munthe-Kaas Ragnhild, Næss Halvor, Pendlebury Sarah T, Seljeseth Yngve Muller, Saltvedt Ingvild
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU Norwegian University of Science and Technology, Trondheim, Norway.
Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
BMC Neurol. 2018 Nov 26;18(1):193. doi: 10.1186/s12883-018-1198-x.
Early and late onset post-stroke cognitive impairment (PCI) contributes substantially to disability following stroke, and is a high priority within stroke research. The aetiology for PCI is complex and related to the stroke itself, brain resilience, comorbid brain diseases, prestroke vulnerability and complications during the hospital stay. The aim of the Norwegian Cognitive Impairment After Stroke study (Nor-COAST) is to quantify and measure levels of cognitive impairments in a general Norwegian stroke population and to identify biological and clinical markers associated with prognosis for cognitive disorders following incident stroke. The study will be organised within five work packages: 1) Incidence and trajectories 2) Pathological mechanisms 3) Development of a risk score 4) Impact of physical activity and 5) Adherence to secondary prevention.
Nor-COAST is an ongoing multicentre (five participating hospitals), prospective, cohort study with consecutive inclusion during the acute phase and with follow-up at three and 18 months, and at three years. Inclusion criteria are stroke defined according to the WHO criteria. During the recruitment period from 18.05.2015 to 31.03.2017, 816 participants have been included. Cognitive impairment will be classified according to the DSM-5 criteria using a consensus group. Cognitive function is assessed by a standardised neuropsychological test battery, the Montreal Cognitive Assessment, Trail making A and B, ten-word immediate and delayed recall test, the Controlled Oral Word Association, Global Deterioration Scale and proxy based information by and the Ascertain Dementia 8 item informant questionnaire. Biomarkers include magnetic resonance imaging, routine blood samples and bio-banking. Clinical assessments include characteristics of the stroke, comorbidity, delirium, frailty and tests for cognitive and physical function, sensor based activity monitoring and adherence to secondary prophylaxis.
Nor-COAST is the first Norwegian multicentre study to quantify burden of PCI that will provide reliable estimates in a general stroke population. A multidisciplinary approach aiming to identify biomarkers and clinical markers of overall prognosis will add new knowledge about risk profiles, including pre-stroke vulnerability and modifiable factors such as physical activity and secondary prophylaxis of relevance for clinical practice and later intervention studies.
ClinicalTrials.gov: NCT02650531 . Retrospectively registered January 8, 2016. First participant included May 18, 2015.
卒中后早期和晚期认知障碍（PCI）是卒中后致残的重要原因，也是卒中研究的重点。PCI的病因复杂，与卒中本身、脑弹性、合并的脑部疾病、卒中前的易损性以及住院期间的并发症有关。挪威卒中后认知障碍研究（Nor-COAST）的目的是量化和测量挪威普通卒中人群的认知障碍水平，并确定与首次卒中后认知障碍预后相关的生物学和临床标志物。该研究将分为五个工作包进行：1）发病率和病程 2）病理机制 3）风险评分的制定 4）体育活动的影响 5）二级预防的依从性。
Nor-COAST是一项正在进行的多中心（五家参与医院）前瞻性队列研究，在急性期连续纳入患者，并在3个月、18个月和3年时进行随访。纳入标准为根据世界卫生组织标准定义的卒中。在2015年5月18日至2017年3月31日的招募期间，已纳入816名参与者。将使用一个共识小组根据DSM-5标准对认知障碍进行分类。认知功能通过标准化的神经心理测试组合进行评估，包括蒙特利尔认知评估、连线测验A和B、10个单词的即时和延迟回忆测试、控制口语单词联想、总体衰退量表以及基于代理人的信息和痴呆筛查8项知情者问卷。生物标志物包括磁共振成像、常规血液样本和生物样本库。临床评估包括卒中的特征、合并症、谵妄、虚弱以及认知和身体功能测试、基于传感器的活动监测和二级预防的依从性。
Nor-COAST是挪威第一项量化PCI负担的多中心研究，将为普通卒中人群提供可靠的估计。旨在识别总体预后的生物标志物和临床标志物的多学科方法将增加有关风险概况的新知识，包括卒中前的易损性以及可改变的因素，如体育活动和二级预防，这些对临床实践和后续干预研究具有重要意义。
ClinicalTrials.gov：NCT02650531。2016年1月8日进行回顾性注册。第一名参与者于2015年5月18日纳入。
