Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Department of Neurology, University Hospital and University of Zurich, Zürich, Switzerland.
Cerebrovasc Dis. 2023;52(2):123-129. doi: 10.1159/000525918. Epub 2022 Aug 29.
Cardiac rhythm monitoring is performed to search for atrial fibrillation (AF) after ischaemic stroke or transient ischaemic attack (TIA). Prolonged cardiac rhythm monitoring increases AF detection but is challenging to implement in many healthcare settings and is not needed for all people after ischaemic stroke/TIA. We aimed to develop and validate a model that includes clinical, electrocardiogram (ECG), blood-based, and genetic biomarkers to identify people with a low probability of AF detection after ischaemic stroke or TIA. We will recruit 675 consenting participants who are aged over 18 years, who were admitted with ischaemic stroke or TIA in the 5 days prior, who are not known to have AF, and who would be suitable for anticoagulation if AF is found. We will collect baseline demographic and clinical data, a 12-lead ECG, and a venous blood sample for blood biomarkers (including midregional pro-atrial natriuretic peptide, MRproANP) and genetic data. We will perform up to 28 days of cardiac rhythm monitoring using an R-test or patch device to search for AF in all participants. The sample size of 675 participants is based on true sensitivity of 92.5%, null hypothesis sensitivity of 80%, 80% power, and 5% significance. The primary outcome is AF detection ≥30 s duration during 28 days of cardiac rhythm monitoring. Secondary outcomes are AF detection at 1-year, recurrent cardiovascular events, and mortality and will be identified by electronic linkage and telephone follow-up. The results will guide the development of a more personalized care pathway to search for AF after ischaemic stroke or TIA. This could help to reduce cardiac rhythm monitoring for people with a low probability of AF detection and allow more intensive cardiac monitoring to be focused on people who are more likely to have AF and benefit. Participants will be consented for their data to be used in future research studies, providing a rich resource for stroke and cardiovascular research communities.
心脏节律监测用于寻找缺血性卒中和短暂性脑缺血发作（TIA）后的心房颤动（AF）。延长心脏节律监测可以提高 AF 的检出率，但在许多医疗保健环境中实施起来具有挑战性，并且并非所有缺血性卒中和 TIA 后的患者都需要进行。我们旨在开发和验证一种模型，该模型包含临床、心电图（ECG）、血液和遗传生物标志物，以识别缺血性卒中和 TIA 后 AF 检出率低的人群。我们将招募 675 名符合条件的参与者，他们年龄在 18 岁以上，在入组前 5 天内因缺血性卒中和 TIA 入院，已知无 AF，且如果发现 AF，适合抗凝治疗。我们将收集基线人口统计学和临床数据、12 导联心电图和静脉血样，用于血液生物标志物（包括中段 pro 心房利钠肽，MRproANP）和遗传数据。我们将对所有参与者进行长达 28 天的心脏节律监测，使用 R-test 或贴片设备来寻找 AF。该样本量为 675 名参与者，基于 92.5%的真实敏感性、80%的无效假设敏感性、80%的功效和 5%的显著性。主要结局是在 28 天的心脏节律监测期间≥30s 的 AF 检出率。次要结局是 1 年时的 AF 检出率、复发性心血管事件和死亡率，将通过电子链接和电话随访来确定。研究结果将指导开发更个性化的缺血性卒中和 TIA 后寻找 AF 的护理途径。这有助于减少 AF 检出率低的人群的心脏节律监测，并使更集中的心脏监测集中在更可能患有 AF 并受益的人群。参与者同意将其数据用于未来的研究，为卒中及心血管研究社区提供了丰富的资源。
