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Am Heart J. 2016 Feb;172:19-25. doi: 10.1016/j.ahj.2015.10.010. Epub 2015 Oct 21.

Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS): Rationale and design of a prospective randomized multicenter study.

Author information

  • 1Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Stroke Society, Berlin, Germany; German Atrial Fibrillation Network Association, Berlin, Germany. Electronic address: georg.haeusler@charite.de.
  • 2German 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.
  • 3Institute of Clinical Epidemiology and Biometry & Comprehensive Heart Failure Center, University of Würzburg, Clinical Trial Centre Würzburg, University Hospital Würzburg, Würzburg, Germany.
  • 4Department of Cardiology, Klinik für Innere Medizin III, Homburg/Saar, Germany.
  • 5German Stroke Society, Berlin, Germany.
  • 6Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
  • 7Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • 8German Stroke Society, Berlin, Germany; Department of Neurology, Vivantes Klinikum Neukölln, Berlin, Germany.
  • 9German Stroke Society, Berlin, Germany; Department of Neurology, Asklepios Klinik Altona, Hamburg, Germany.
  • 10German Stroke Society, Berlin, Germany; Department of Stroke Medicine, Imperial College London, London, UK.
  • 11Center for Stroke Research Berlin & Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Stroke Society, Berlin, Germany; Excellence Cluster NeuroCure, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Center for Neurodegenerative Diseases, Partner Site Berlin, Berlin, Germany; German Center for Cardiovascular Diseases, Partner Site Berlin, Berlin, Germany.

Abstract

BACKGROUND:

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.

STUDY DESIGN:

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.

OUTCOMES:

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.

CONCLUSION:

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.

Copyright © 2015 Elsevier Inc. All rights reserved.

PMID:
26856211
[PubMed - in process]
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