Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Bispebjerg Hospital, Copenhagen, Denmark
Department of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Bispebjerg Hospital, Copenhagen, Denmark.
BMJ Open. 2022 May 11;12(5):e061018. doi: 10.1136/bmjopen-2022-061018.
Despite workup for the aetiology of ischaemic stroke, about 25% of cases remain unexplained. Paroxysmal atrial fibrillation is typically suspected but often not detected. Even if atrial fibrillation (AF) is detected, the quantitative threshold of clinically relevant AF remains unclear. Emerging evidence suggests that left atrial (LA) functional and structural abnormalities may convey a risk of ischaemic stroke in which AF is only one of several features. These abnormalities have been termed 'atrial cardiomyopathy'. This study uses cardiac magnetic resonance (CMR) to evaluate atrial cardiomyopathy among patients with stroke of undetermined aetiology compared with those with an attributable mechanism and controls without established cardiovascular disease.
This cross-sectional and prospective cohort study included 100 patients with recent ischaemic stroke and 50 controls with no established cardiovascular disease. The study will assess LA structural and functional abnormalities with CMR. Inclusion began in March 2019, and follow-up is planned to be complete in January 2023. There are two scheduled follow-ups: (1) 18 months after individual inclusion, counting from the index diagnostic MRI of the brain, (2) end of study follow-up at 18 months after inclusion of the last patient, assessing the incidence of recurrent ischaemic stroke, AF and cardiovascular death. The primary endpoint is the extent of CMR-assessed atrial fibrosis in the LA at baseline. The study is powered to detect a difference of 6% fibrosis between stroke of undetermined aetiology and stroke of known mechanism with a SD of 9%, a significance level of 0.05, and power of 80%.
This study has been approved by the Danish National Committee on Health Research Ethics (H-18055313). All participants in the study signed informed consent. Results from the study will be published in peer-reviewed journals regardless of the outcome.
NCT03830983.
尽管对缺血性中风的病因进行了检查，但仍有约 25%的病例原因不明。阵发性心房颤动通常被怀疑，但往往无法检测到。即使检测到心房颤动（AF），临床上相关的 AF 的定量阈值仍不清楚。新出现的证据表明，左心房（LA）功能和结构异常可能与 AF 只是几种特征之一的缺血性中风风险相关。这些异常被称为“心房心肌病”。本研究使用心脏磁共振（CMR）评估原因不明的中风患者与有明确病因机制的中风患者和无明确心血管疾病的对照组之间的心房心肌病。
本横断面前瞻性队列研究纳入了 100 例近期缺血性中风患者和 50 例无明确心血管疾病的对照组。该研究将使用 CMR 评估 LA 结构和功能异常。纳入始于 2019 年 3 月，计划于 2023 年 1 月完成随访。有两次预定随访：（1）从脑的索引诊断 MRI 开始计算，个体纳入后 18 个月，（2）最后一名患者纳入后 18 个月的研究结束随访，评估复发性缺血性中风、AF 和心血管死亡的发生率。主要终点是基线时 LA 中 CMR 评估的心房纤维化程度。该研究具有检测原因不明的中风和已知机制的中风之间 LA 纤维化程度差异 6%的能力，标准差为 9%，显著性水平为 0.05，功率为 80%。
本研究已获得丹麦国家健康研究伦理委员会（H-18055313）的批准。研究中的所有参与者都签署了知情同意书。无论结果如何，研究结果都将发表在同行评议的期刊上。
NCT03830983。
