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Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring—Find-AFRANDOMISED —rationale and design - 26/09/14

Doi : 10.1016/j.ahj.2014.06.018 
Mark Weber-Krüger, MD a, Götz Gelbrich, PhD b, c, Raoul Stahrenberg, MD d, Jan Liman, MD e, Pawel Kermer, MD f, Gerhard F. Hamann, MD g, Joachim Seegers, MD h, Klaus Gröschel, MD i, j, Rolf Wachter, MD a, , j
on behalf of the

Find-AFRANDOMISED investigators

a Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany 
b Institute for Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany 
c Clinical Trial Centre, University of Würzburg, Würzburg, Germany 
d Helios Albert-Schweitzer-Kliniken Northeim, Germany 
e Clinic for Neurology, University of Göttingen, Göttingen, Germany 
f Department of Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany 
g Department of Neurology and Neurological Rehabilitation, Bezirkskliniken Günzburg, Germany 
h Department of General Medicine II, University of Regensburg, Regensburg, Germany 
i Clinic and Polyclinic for Neurology, University of Mainz, Mainz, Germany 

Reprint requests: Rolf Wachter, Clinic for Cardiology and Pneumology, University of Göttingen, Robert-Koch-Str. 40, 37075 Göttingen, Germany.

Résumé

Background

Detecting paroxysmal atrial fibrillation (AF) in patients with ischemic strokes presenting in sinus rhythm is challenging because episodes are often short, occur randomly, and are frequently asymptomatic. If AF is detected, recurrent thromboembolism can be prevented efficiently by oral anticoagulation. Numerous uncontrolled studies using various electrocardiogram (ECG) devices have established that prolonged ECG monitoring increases the yield of AF detection, but most established procedures are time-consuming and costly. The few randomized trials are mostly limited to cryptogenic strokes. The optimal method, duration, and patient selection remain unclear. Repeated prolonged continuous Holter ECG monitoring to detect paroxysmal AF within an unspecific stroke population may prove to be a widely applicable, effective secondary prevention strategy.

Study Design

Find-AFRANDOMISED is a randomized and controlled prospective multicenter trial. Four hundred patients 60 years or older with manifest (symptoms ≥24 hours or acute computed tomography/magnetic resonance imaging lesion) and acute (symptoms ≤7 days) ischemic strokes will be included at 4 certified stroke centers in Germany. Those with previously diagnosed AF/flutter, indications/contraindications for oral anticoagulation, or obvious causative blood vessel pathologies will be excluded. Patients will be randomized 1:1 to either enhanced and prolonged Holter ECG monitoring (10 days at baseline and after 3 and 6 months) or standard of care (≥24-hour continuous ECG monitoring, according to current stroke guidelines). All patients will be followed up for at least 12 months.

Outcomes

The primary end point is newly detected AF (≥30 seconds) after 6 months, confirmed by an independent adjudication committee. We plan to complete recruitment in autumn 2014. First results can be expected by spring 2016.

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Plan


 RCT No. NCT01855035.
 Disclosures: Find-AFRANDOMISED is sponsored by an unrestricted grant from Boehringer Ingelheim. Mark Weber-Krüger received a travel grant from Pfizer. Pawel Kermer serves as a member in advisory boards/received speaker's honoraria from Bayer Healthcare, Boehringer Ingelheim, and Bristol-Myer-Squibb. Klaus Gröschel received speaker's honoraria from Boehringer Ingelheim, Bristol-Myer-Squibb, and Pfizer. Rolf Wachter received speaker's honoraria from Bayer Healthcare, Boehringer Ingelheim, Medtronic, and Pfizer. He acted as a local principal investigator in the CRYSTAL-AF study and is part of the Steering Committee of the Reveal-AF trial, both sponsored by Medtronic.


© 2014  Mosby, Inc. Tous droits réservés.
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Vol 168 - N° 4

P. 438 - octobre 2014 Retour au numéro
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