Infarct volume-based subgroup selection in acute ischemic stroke trials

Stroke; a Journal of Cerebral Circulation
Anna KufnerAXIS2 investigators

Abstract

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. 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. 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. Lesion diameter measures may enable multicentric patient recruitment with a prespecified minimal infarct volume. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927836.

Associated Clinical Trials

References

Jun 16, 2007·Stroke; a Journal of Cerebral Circulation·Maarten G LansbergUNKNOWN DEFUSE Investigators
Mar 31, 2011·Journal of Neuroimaging : Official Journal of the American Society of Neuroimaging·Salvador PedrazaJoaquín Serena
Aug 22, 2013·Stroke; a Journal of Cerebral Circulation·E Bernd RingelsteinUNKNOWN AXIS 2 Investigators

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