Department of Laboratory Medicine, Institute of Biomedicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Region Västra Götaland, Sahlgrenska University Hospital, Department of Research, Development, Education and Innovation, Gothenburg, Sweden.
BMJ Open. 2023 May 10;13(5):e072493. doi: 10.1136/bmjopen-2023-072493.
Comprehensive studies mapping domain-specific trajectories of recovery after stroke and biomarkers reflecting these processes are scarce. We, therefore, initiated an exploratory prospective observational study of stroke cases with repeated evaluation, the . We aim to capture trajectories of recovery from different impairments, including cognition, in combination with broad profiling of blood and imaging biomarkers of the recovery.
We recruit individuals with first-ever stroke at the stroke unit at the Sahlgrenska University Hospital, Sweden, to FIND. The inclusion started early 2018 and we aim to enrol minimum 500 patients. Neurological and cognitive impairments across multiple domains are assessed using validated clinical assessment methods, advanced neuroimaging is performed and blood samples for biomarker measuring (protein, RNA and DNA) at inclusion and follow-up visits at 3 months, 6 months, 1 year, 2 years and 5 years poststroke. At baseline and at each follow-up visit, we also register clinical variables known to influence outcomes such as prestroke functioning, stroke severity, acute interventions, rehabilitation, other treatments, socioeconomic status, infections (including COVID-19) and other comorbidities. Recurrent stroke and other major vascular events are identified continuously in national registers.
FIND composes a unique stroke cohort with detailed phenotyping, repetitive assessments of outcomes across multiple neurological and cognitive domains and patient-reported outcomes as well as blood and imaging biomarker profiling. Ethical approval for the FIND study has been obtained from the Regional Ethics Review Board in Gothenburg and the Swedish Ethics Review Board. The results of this exploratory study will provide novel data on the time course of recovery and biomarkers after stroke. The description of this protocol will inform the stroke research community of our ongoing study and facilitate comparisons with other data sets.
The protocol is registered at http://www.
gov, Study ID: NCT05708807.
综合研究描绘了中风后特定领域恢复的轨迹，以及反映这些过程的生物标志物，但此类研究仍然匮乏。因此，我们开展了一项探索性的、前瞻性的、观察性研究，即 FIND 研究。该研究对中风病例进行重复评估，旨在捕获不同损伤（包括认知功能损伤）的恢复轨迹，并广泛分析与恢复相关的血液和影像学生物标志物。
我们在瑞典萨尔格伦斯卡大学医院的中风病房招募首次中风的个体入组 FIND 研究。纳入工作于 2018 年初开始，我们的目标是入组至少 500 名患者。使用经过验证的临床评估方法评估多个领域的神经和认知损伤，进行高级神经影像学检查，并在入组时以及 3 个月、6 个月、1 年、2 年和 5 年后的随访时采集血液样本，用于生物标志物测量（蛋白质、RNA 和 DNA）。在基线和每次随访时，我们还记录了已知会影响结局的临床变量，如发病前的功能、中风严重程度、急性干预、康复、其他治疗、社会经济状况、感染（包括 COVID-19）和其他合并症。中风和其他主要血管事件的复发情况在国家登记处持续进行识别。
FIND 研究组成了一个独特的中风队列，具有详细的表型特征、多个神经和认知领域的结局重复评估以及患者报告结局，还有血液和影像学生物标志物的特征分析。FIND 研究已获得哥德堡地区伦理审查委员会和瑞典伦理审查委员会的批准。这项探索性研究的结果将提供中风后恢复和生物标志物的时间进程的新数据。本方案的描述将使中风研究界了解我们正在进行的研究，并促进与其他数据集的比较。
方案在 http://www. 注册。
gov，研究 ID：NCT05708807。
