Infarct volume-based subgroup selection in acute ischemic stroke trials

Stroke. 2015 May;46(5):1368-70. doi: 10.1161/STROKEAHA.114.008115. Epub 2015 Mar 12.

Abstract

Background and purpose: 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.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927836.

Keywords: clinical trial; infarction; stroke.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Brain Ischemia / classification
  • Brain Ischemia / pathology*
  • Cerebral Infarction / classification
  • Cerebral Infarction / pathology*
  • Clinical Trials as Topic
  • Diffusion Magnetic Resonance Imaging
  • Female
  • Humans
  • Image Processing, Computer-Assisted
  • Infarction, Middle Cerebral Artery / pathology
  • Male
  • Middle Aged
  • Patient Selection
  • Stroke / classification
  • Stroke / pathology*

Associated data

  • ClinicalTrials.gov/NCT00927836