Post-stroke cognitive impairment (PSCI) is common. However, the underlying pathophysiology remains largely unknown. Understanding the role of microvascular changes and finding markers that can predict PSCI, could be a first step towards better screening and management of PSCI. Capillary dysfunction is a pathological feature of cerebral small vessel disease and may play a role in the mechanisms underlying PSCI. Extracellular vesicles (EVs) are secreted from cells and may act as disease biomarkers. We aim to investigate the role of capillary dysfunction in PSCI and the associations between EV characteristics and cognitive function one year after acute ischemic stroke (AIS) and transient ischemic attack (TIA). The ENIGMA study is a single-centre prospective clinical observational study conducted at Aarhus University Hospital, Denmark. Consecutive patients with AIS and TIA are included and followed for one year with follow-up visits at three and 12 months. An MRI is performed at 24 h and 12 months follow-up. EV characteristics will be characterised from blood samples drawn at 24 h and three months follow-up. Cognitive function is assessed three and 12 months after AIS and TIA using the Repeatable Battery for the Assessment of Neuropsychological Status. Using novel imaging and molecular biological techniques the ENIGMA study will provide new knowledge about the vascular contributions to cognitive decline and dementia. The study is retrospectively registered as an ongoing observational study at ClinicalTrials.gov with the identifier NCT06257823.

中文翻译：

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探索血管对认知障碍和痴呆的影响 (ENIGMA)：前瞻性观察研究方案

中风后认知障碍（PSCI）很常见。然而，潜在的病理生理学仍然很大程度上未知。了解微血管变化的作用并寻找可以预测 PSCI 的标记物可能是更好地筛查和管理 PSCI 的第一步。毛细血管功能障碍是脑小血管疾病的病理特征，可能在 PSCI 的机制中发挥作用。细胞外囊泡 (EV) 由细胞分泌，可作为疾病生物标志物。我们的目的是研究毛细血管功能障碍在 PSCI 中的作用以及急性缺血性卒中 (AIS) 和短暂性脑缺血发作 (TIA) 一年后 EV 特征与认知功能之间的关联。 ENIGMA研究是一项在丹麦奥胡斯大学医院进行的单中心前瞻性临床观察研究。连续患有 AIS 和 TIA 的患者被纳入研究，并随访一年，并在三个月和 12 个月进行随访。随访 24 小时和 12 个月时进行 MRI 检查。 EV 特征将通过 24 小时和三个月随访时抽取的血液样本来表征。使用用于评估神经心理状态的可重复电池在 AIS 和 TIA 后 3 个月和 12 个月评估认知功能。 ENIGMA 研究利用新颖的成像和分子生物学技术，将提供有关血管对认知能力下降和痴呆的影响的新知识。该研究在 ClinicalTrials.gov 上回顾性注册为一项正在进行的观察性研究，标识符为 NCT06257823。