Haeusler Karl Georg, Kirchhof Paulus, Heuschmann Peter U, Laufs Ulrich, Busse Otto, Kunze Claudia, Thomalla Götz, Nabavi Darius G, Röther Joachim, Veltkamp Roland, Endres Matthias
Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Stroke Society, Berlin, Germany; German Atrial Fibrillation Network Association, Berlin, Germany.
German Atrial Fibrillation Network Association, Berlin, Germany; Institute of Cardiovascular Science, University of Birmingham, and SWBH and UHB NHS Trusts, Birmingham, UK; Department of Cardiovascular Medicine, Hospital of the University of Münster, Münster, Germany.
Am Heart J. 2016 Feb;172:19-25. doi: 10.1016/j.ahj.2015.10.010. Epub 2015 Oct 21.
Atrial fibrillation (AF) is estimated to account for approximately every fifth ischemic stroke. In routine clinical practice, detection of undiagnosed, clinically silent AF represents a major diagnostic challenge, and in up to 30% of patients with ischemic stroke, AF remains undetected. The MonDAFIS study has been designed to quantify the diagnostic yield and clinical relevance of systematic electrocardiogram (ECG) monitoring for patients with acute ischemic stroke during the subsequent in hospital stay.
A prospective randomized multicenter study in 3,470 patients with acute ischemic stroke or transient ischemic attack and without known AF on hospital admission. Over a period of approximately 2years, patients will be enrolled in about 30 German-certified stroke units and randomized 1:1 to receive either usual stroke unit diagnostic procedures for detection of AF (control group) or usual stroke unit diagnostic procedures plus standardized and centrally analyzed Holter ECG recording for up to 7days in hospital (intervention group). Results of the ECG core laboratory analysis will be provided to the patients and treating physicians. All patients will be followed up for treatment and cardiovascular outcomes at 6, 12, and 24months after enrollment.
The primary outcome of the randomized MonDAFIS study is the proportion of patients who receive anticoagulation therapy 12months after the index stroke. Secondary outcomes include the number of stroke patients with newly detected AF in hospital and the rate of recurrent stroke, major bleedings, myocardial infarction, or death 6, 12, and 24months after the index event. MonDAFIS will also explore patient-reported adherence to anticoagulants, the clinical relevance of short atrial tachycardia, or excessive supraventricular ectopic activity as well as cost-effectiveness of prolonged, centrally analyzed ECG recordings.
MonDAFIS will be the largest study to date to evaluate whether a prolonged and systematic ECG monitoring during the initial in hospital stay has an impact on secondary stroke prevention. In addition, prognosis as well as adherence to medication up to 2 years after the index stroke will be analyzed. The primary results of the MonDAFIS study may have the potential to change the current guidelines recommendations regarding ECG workup after ischemic stroke.
据估计，每五例缺血性卒中中约有一例由心房颤动（AF）引起。在常规临床实践中，检测未确诊的、临床上无症状的AF是一项重大的诊断挑战，在高达30%的缺血性卒中患者中，AF仍未被检测到。MonDAFIS研究旨在量化对急性缺血性卒中患者在随后住院期间进行系统性心电图（ECG）监测的诊断率及临床相关性。
一项前瞻性随机多中心研究，纳入3470例急性缺血性卒中或短暂性脑缺血发作且入院时无已知AF的患者。在大约2年的时间里，患者将被纳入约30个德国认证的卒中单元，并按1:1随机分组，分别接受常规卒中单元检测AF的诊断程序（对照组）或常规卒中单元诊断程序加在医院进行长达7天的标准化且集中分析的动态心电图记录（干预组）。ECG核心实验室分析结果将提供给患者及治疗医师。所有患者将在入组后6个月、12个月和24个月进行随访，观察治疗及心血管结局。
随机的MonDAFIS研究的主要结局是首次卒中后12个月接受抗凝治疗的患者比例。次要结局包括住院期间新检测到AF的卒中患者数量以及首次事件后6个月、12个月和24个月的复发性卒中、大出血、心肌梗死或死亡发生率。MonDAFIS还将探讨患者报告的抗凝剂依从性、短阵房性心动过速或过多室上性异位活动的临床相关性以及延长的、集中分析的ECG记录的成本效益。
MonDAFIS将是迄今为止评估在住院初期进行延长的系统性ECG监测是否对二级卒中预防有影响的最大规模研究。此外，还将分析首次卒中后长达2年的预后及药物依从性。MonDAFIS研究的主要结果可能有潜力改变目前关于缺血性卒中后ECG检查的指南建议。
