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 2 years, 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 7 days 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 24 months after enrollment.
Outcomes
The primary outcome of the randomized MonDAFIS study is the proportion of patients who receive
anticoagulation therapy 12 months 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
24 months after the index event. MonDAFIS will also explore patient-reported adherence to anticoagulants, the clinical elevance 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. (Am Heart J
2016;172:19-25.)