Mark Weber-Krüger1, Götz Gelbrich2, Raoul Stahrenberg3, Jan Liman4, Pawel Kermer5, Gerhard F Hamann6, Joachim Seegers7, Klaus Gröschel8, Rolf Wachter9. 1. Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany. 2. Institute for Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany; Clinical Trial Centre, University of Würzburg, Würzburg, Germany. 3. Helios Albert-Schweitzer-Kliniken Northeim, Germany. 4. Clinic for Neurology, University of Göttingen, Göttingen, Germany. 5. Department of Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany. 6. Department of Neurology and Neurological Rehabilitation, Bezirkskliniken Günzburg, Germany. 7. Department of General Medicine II, University of Regensburg, Regensburg, Germany. 8. Clinic and Polyclinic for Neurology, University of Mainz, Mainz, Germany. 9. Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany. Electronic address: wachter@med.uni-goettingen.de.
Abstract
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.
RCT Entities:
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.
Authors: Slaven Pikija; Laszlo K Sztriha; J Sebastian Mutzenbach; Stefan M Golaszewski; Johann Sellner Journal: CNS Drugs Date: 2017-09 Impact factor: 5.749
Authors: Katrin Wasser; Mark Weber-Krüger; Falko Jürries; Jan Liman; Gerhard F Hamann; Pawel Kermer; Timo Uphaus; Evgeny Protsenko; Joachim Seegers; Meinhard Mende; Klaus Gröschel; Rolf Wachter Journal: PLoS One Date: 2019-05-09 Impact factor: 3.240
Authors: Rolf Wachter; Mark Weber-Krüger; Gerhard F Hamann; Pawel Kermer; Jan Liman; Meinhard Mende; Joachim Seegers; Katrin Wasser; Sonja Gröschel; Timo Uphaus; Holger Poppert; Martin Köhrmann; Markus Zabel; Ulrich Laufs; Peter U Heuschmann; David Conen; Klaus Gröschel Journal: J Stroke Date: 2021-12-17 Impact factor: 6.967
Authors: Karl Georg Haeusler; Ulrike Grittner; Jochen B Fiebach; Matthias Endres; Thomas Krause; Christian H Nolte Journal: BMC Neurol Date: 2015-10-22 Impact factor: 2.474