The NORwegian atrial fibrillation self-SCREENing (NORSCREEN) trial: rationale and design of a randomized controlled trial.

IF 7.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Europace Pub Date : 2024-10-03 DOI:10.1093/europace/euae228
Miroslav Boskovic, Jarle Jortveit, Marius Blørstad Haraldsen, Trygve Berge, Johan Engdahl, Maja-Lisa Løchen, Peter Schuster, Edvard Liljedahl Sandberg, Jostein Grimsmo, Dan Atar, Ole-Gunnar Anfinsen, Are Hugo Pripp, Bjørnar Leangen Grenne, Sigrun Halvorsen
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Abstract

Aims: Atrial fibrillation (AF) is a common arrhythmia, and many cases of AF may be undiagnosed. Whether screening for AF and subsequent treatment if AF is detected can improve long-term outcome remains an unsettled question. The primary aim of the NORwegian atrial fibrillation self-SCREENing (NORSCREEN) trial is to assess whether self-screening for AF with continuous electrocardiogram (ECG) for 3-7 days in individuals aged 65 years or older with at least one additional risk factor for stroke, and initiation of guideline-recommended therapy in patients with detected AF, will reduce the occurrence of stroke.

Methods and results: This study is a nationwide open, siteless, randomized, controlled trial. Individuals ≥65 years of age are randomly identified from the National Population Register of Norway and are invited to take a digital inclusion/exclusion test. Individuals passing the inclusion/exclusion test are randomized to either the intervention group or the control group. A total of 35 000 participants will be enrolled. In the intervention group, self-screening is performed continuously over 3-7 days at home with a patch ECG device (ECG247) at inclusion and after 12-18 months. If AF is detected, guideline-recommended therapy will be initiated. Patients will be followed up for 5 years through national health registries. The primary outcome is time to a first stroke (ischaemic or haemorrhagic stroke). The first participant in the NORSCREEN trial was enrolled on 1 September 2023.

Conclusion: The results from the NORSCREEN trial will provide new insights regarding the efficacy of digital siteless self-screening for AF with respect to stroke prevention in individuals at an increased risk of stroke.

Trial registration: Clinical trials: NCT05914883.

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挪威心房颤动自我检测试验(NORSCREEN):随机对照试验的原理与设计。
背景和目的:心房颤动(房颤)是一种常见的心律失常,许多病例可能无法确诊。筛查心房颤动并在发现心房颤动后进行治疗是否能改善长期预后,目前尚无定论。挪威心房颤动自我筛查试验(NORSCREEN)的主要目的是评估在 65 岁或以上、至少有一个额外中风风险因素的人群中进行为期 3-7 天的连续心电图心房颤动自我筛查,并对检测出心房颤动的患者启动指南推荐的治疗,是否能减少中风的发生:该研究是一项全国范围的随机、开放、无坐位对照试验。从挪威国家人口登记册中随机确定年龄≥65 岁的个人,并邀请他们参加数字纳入/排除测试。通过包容性/排斥性测试的人将被随机分配到干预组或对照组。总共将有 35000 名参与者参加。干预组在纳入时和 12-18 个月后连续 3-7 天在家使用贴片式心电图设备 (ECG247) 进行自我筛查。如果检测到房颤,将启动指南推荐的治疗。将通过国家健康登记处对患者进行为期五年的随访。主要结果是中风发生时间。NORSCREEN 试验的首位参与者于 2023 年 9 月 1 日注册:NORSCREEN试验的结果将为数字无坐位房颤自我筛查在预防中风高危人群中的疗效提供新的见解。
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来源期刊
Europace
Europace 医学-心血管系统
CiteScore
10.30
自引率
8.20%
发文量
851
审稿时长
3-6 weeks
期刊介绍: EP - Europace - European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology of the European Heart Rhythm Association of the European Society of Cardiology. The journal aims to provide an avenue of communication of top quality European and international original scientific work and reviews in the fields of Arrhythmias, Pacing and Cellular Electrophysiology. The Journal offers the reader a collection of contemporary original peer-reviewed papers, invited papers and editorial comments together with book reviews and correspondence.
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