title: Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): an open-label randomised controlled trial.
abstract: BACKGROUND
  Atrial fibrillation is a major risk factor for recurrent ischaemic stroke, but often remains undiagnosed in patients who have had an acute ischaemic stroke. Enhanced and prolonged Holter-electrocardiogram-monitoring might increase detection of atrial fibrillation. We therefore investigated whether enhanced and prolonged rhythm monitoring was better for detection of atrial fibrillation than standard care procedures in patients with acute ischaemic stroke.
  
  
  METHODS
  Find-AFrandomisedis an open-label randomised study done at four centres in Germany. We recruited patients with acute ischaemic stroke (symptoms for 7 days or less) aged 60 years or older presenting with sinus rhythm and without history of atrial fibrillation. Patients were included irrespective of the suspected cause of stroke, unless they had a severe ipsilateral carotid or intracranial artery stenosis, which were the exclusion criteria. We used a computer-generated allocation sequence to randomly assign patients in a 1:1 ratio with permuted block sizes of 2, 4, 6, and 8, stratified by centre, to enhanced and prolonged monitoring (ie, 10-day Holter-electrocardiogram [ECG]-monitoring at baseline, and at 3 months and 6 months of follow-up) or standard care procedures (ie, at least 24 h of rhythm monitoring). Participants and study physicians were not masked to group assignment, but the expert committees that adjudicated endpoints were. The primary endpoint was the occurrence of atrial fibrillation or atrial flutter (30 sec or longer) within 6 months after randomisation and before stroke recurrence. Because Holter ECG is a widely used procedure and not known to harm patients, we chose not to assess safety in detail. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01855035.
  
  
  RESULTS
  Between May 8, 2013, and Aug 31, 2014, we recruited 398 patients. 200 patients were randomly assigned to the enhanced and prolonged monitoring group and 198 to the standard care group. After 6 months, we detected atrial fibrillation in 14% of 200 patients in the enhanced and prolonged monitoring group (27 patients) versus 5% in the control group (nine of 198 patients, absolute difference 9·0%; 95% CI 3·4-14·5, p=0·002; number needed to screen 11).
  
  
  CONCLUSIONS
  Enhanced and prolonged monitoring initiated early in patients with acute ischaemic stroke aged 60 years or older was better than standard care for the detection of atrial fibrillation. These findings support the consideration of all patients aged 60 years or older with stroke for prolonged monitoring if the detection of atrial fibrillation would result in a change in medical management (eg, initiation of anticoagulation).
  
  
  BACKGROUND
  Boehringer Ingelheim.
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany; DZHK (German Centre for Cardiovascular Research), partner site, Göttingen, Germany. Electronic address: wachter@med.uni-goettingen.de.
authors.forename: Rolf
authors.initials: R
authors.lastname: Wachter
authors.affiliation: Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Gröschel
authors.affiliation: Institute for Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany; Clinical Trial Centre, University of Würzburg, Würzburg, Germany.
authors.forename: Götz
authors.initials: G
authors.lastname: Gelbrich
authors.affiliation: Clinic for Neurology and Neurorehabilitation, Bezirkskrankenhaus Günzburg, Günzburg, Germany.
authors.forename: Gerhard F
authors.initials: GF
authors.lastname: Hamann
authors.affiliation: Clinic for Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany.
authors.forename: Pawel
authors.initials: P
authors.lastname: Kermer
authors.affiliation: Clinic for Neurology, University of Göttingen, Göttingen, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Liman
authors.affiliation: Department of Internal Medicine II, Division of Cardiology, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Seegers
authors.affiliation: Clinic for Neurology, University of Göttingen, Göttingen, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Wasser
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany; DZHK (German Centre for Cardiovascular Research), partner site, Göttingen, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Schulte
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany.
authors.forename: Falko
authors.initials: F
authors.lastname: Jürries
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany; DZHK (German Centre for Cardiovascular Research), partner site, Göttingen, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Messerschmid
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany; DZHK (German Centre for Cardiovascular Research), partner site, Göttingen, Germany.
authors.forename: Nico
authors.initials: N
authors.lastname: Behnke
authors.affiliation: Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Sonja
authors.initials: S
authors.lastname: Gröschel
authors.affiliation: Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Timo
authors.initials: T
authors.lastname: Uphaus
authors.affiliation: Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Anne
authors.initials: A
authors.lastname: Grings
authors.affiliation: Department of Neurology, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Tugba
authors.initials: T
authors.lastname: Ibis
authors.affiliation: Clinic for Neurology, Horst-Schmidt-Kliniken, Wiesbaden, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Klimpe
authors.affiliation: Clinic for Neurology, Horst-Schmidt-Kliniken, Wiesbaden, Germany.
authors.forename: Michaela
authors.initials: M
authors.lastname: Wagner-Heck
authors.affiliation: Clinic for Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Arnold
authors.affiliation: Clinic for Neurology, Nordwest-Krankenhaus Sanderbusch, Sande, Germany.
authors.forename: Evgeny
authors.initials: E
authors.lastname: Protsenko
authors.affiliation: Institute for Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany; Clinical Trial Centre, University of Würzburg, Würzburg, Germany; Comprehensive Heart Failure Centre, University of Würzburg, Basel, Switzerland.
authors.forename: Peter U
authors.initials: PU
authors.lastname: Heuschmann
authors.affiliation: Division of Internal Medicine, University Hospital Basel, Basel, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Conen
authors.affiliation: Clinic for Cardiology and Pneumology, University of Göttingen, Göttingen, Germany.
authors.forename: Mark
authors.initials: M
authors.lastname: Weber-Krüger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis; D002545:Brain Ischemia / Q000150:complications*; D004562:Electrocardiography / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018709:Statistics, Nonparametric; D020521:Stroke / Q000175:diagnosis* / Q000209:etiology*; D013997:Time Factors