title: Infarct volume-based subgroup selection in acute ischemic stroke trials.
abstract: OBJECTIVE
  We investigated whether hyperintensities with a diameter of at least 3, 3.5, and 4 cm and visible on at least 3 slices on diffusion-weighted imaging enables patient selection with an infarct volume of ≥15 mL.
  
  
  METHODS
  Consecutive acute stroke patients were screened for the AXIS2 trial and examined according to a standardized magnetic resonance imaging protocol in 65 sites. Diffusion-weighted lesion diameters were measured and compared with volumetric assessments.
  
  
  RESULTS
  Out of 238 patients, 86.2% (N=206) had infarct diameter of at least 3 cm. Volumetric assessments showed infarct volume of ≥15 mL in 157 patients. A cut-off value of 3 cm led to 96.8% sensitivity and 33.3% specificity for predicting lesion volume of ≥15 mL. Analogously, a 3.5 cm cut-off led to 96.8% sensitivity and 50.6% specificity and a 4 cm cut-off led to 91.7% sensitivity and 61.7% specificity.
  
  
  CONCLUSIONS
  Lesion diameter measures may enable multicentric patient recruitment with a prespecified minimal infarct volume.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927836.
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.). anna.kufner@charite.de.
authors.forename: Anna
authors.initials: A
authors.lastname: Kufner
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Anke
authors.initials: A
authors.lastname: Wouters
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Luc
authors.initials: L
authors.lastname: Bracoud
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Rico
authors.initials: R
authors.lastname: Laage
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Armin
authors.initials: A
authors.lastname: Schneider
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Wolf-Rüdiger
authors.initials: WR
authors.lastname: Schäbitz
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Marc
authors.initials: M
authors.lastname: Hermier
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Vincent
authors.initials: V
authors.lastname: Thijs
authors.affiliation: From the Department of Neurology, Center for Stroke Research Berlin, Charité University Hospital Berlin, Germany (A.K., J.B.F.); Experimental Neurology, Department of Neurosciences, KU Leuven-University of Leuven, Leuven, Belgium (A.W., V.T.); Department of Neurology, BioClinica Bio-Imaging Technologies, Lyon France (L.B.); Department of Neurology, Sygnis Bioscience, Im Neuenheimer Feld 515, Heidelberg, Germany (R.L., A.S.); Department of Neurology, Evangelisches Krankenhaus Bielefeld, Germany (W.-R.S.); Department of Neuroradiology, Hospices Civils de Lyon, France (M.H.); VIB, Vesalius Research Center, Laboratory of Neurobiology, B-3000 Leuven, Belgium (V.T.); and Department of Neurology, University Hospitals Leuven, Leuven, Belgium (V.T.).
authors.forename: Jochen B
authors.initials: JB
authors.lastname: Fiebach
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000145:classification / Q000473:pathology*; D002544:Cerebral Infarction / Q000145:classification / Q000473:pathology*; D002986:Clinical Trials as Topic; D038524:Diffusion Magnetic Resonance Imaging; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D020244:Infarction, Middle Cerebral Artery / Q000473:pathology; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D020521:Stroke / Q000145:classification / Q000473:pathology*
keywords: clinical trial; infarction; stroke