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(Stroke. 2008;39:2693.)
© 2008 American Heart Association, Inc.

Editorials

Establishing Final Infarct Volume

Stroke Lesion Evolution Past 30 Days Is Insignificant

Peter D. Schellinger, MD, PhD Jochen B. Fiebach, MD, PhD

From the Department of Neurology (P.D.S.), University at Erlangen, Germany; and the Department of Neurology (J.B.F.), Charité, Berlin, Germany.

Correspondence to Peter D. Schellinger, MD, PhD, Department of Neurology, Schwabachanlage 6, D-91054 Erlangen, Germany. E-mail Peter.Schellinger@uk-erlangen.de

Key Words: acute care • MRI

An extract of the first 250 words of the full text is provided, because this article has no abstract.

See related article, pages 2765–2768.

Surrogate end points in acute stroke trials are manifold, albeit neither the optimum variable nor the optimum time point for assessment at present is known. They serve either as secondary end points or may serve as primary end points in phase 2a and 2b trials or proof of concept studies. Examples of frequently used surrogate end points are early neurological improvement at 24 hours (eg, in NINDS and ECASS 1), recanalization and/or reperfusion at 4 to 8 hours (eg, DEFUSE, DIAS and DEDAS) or >24 hours (eg, secondary end point in EPITHET). Trends toward benefit using clinical scales at phase II have been notoriously poor predictors of clinical outcomes in phase III trials on much larger samples.^1,2 The optimum time point of reperfusion/recanalization assessment is still a matter of debate; however, imaging within 6 hours after a therapeutic intervention is considered as appropriate but also of limited practicality.

Modern imaging may be useful for sample size reductions either if used for patient selection, or as an outcome surrogate, or both. Imaging-guided phase II studies may answer the question of target biological activity in fewer than 200 patients, the sample size typical for phase II trials.³ Selection of patients by diffusion-weighted imaging is also optimally suited for using change in lesion volume compared to final infarct size as a direct measure of a therapeutic effect of the drug. Although optimizing sample selection may lead to smaller sample sizes,³ the greatest advantage of stroke MRI is . . . [Full Text of this Article]

Related Article:

Establishing Final Infarct Volume: Stroke Lesion Evolution Past 30 Days Is Insignificant

Martin R. Gaudinski, Erica C. Henning, Aaron Miracle, Marie Luby, Steven Warach, and Lawrence L. Latour
Stroke 2008 39: 2765-2768. [Abstract] [Full Text] [PDF]