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Clinical Trial
. 2009 Apr;40(4):1332-3.
doi: 10.1161/STROKEAHA.108.528976. Epub 2009 Feb 19.

Clinical and imaging data at 5 days as a surrogate for 90-day outcome in ischemic stroke

Karen C Johnston  1 , Kevin M Barrett, Yong Hong Ding, Douglas P Wagner; Acute Stroke Accurate Prediction Investigators
Affiliations
Clinical Trial

Clinical and imaging data at 5 days as a surrogate for 90-day outcome in ischemic stroke

Karen C Johnston et al. Stroke. 2009 Apr.

Abstract

Background and purpose: A simple, easily measured surrogate outcome measure for use in early treatment trials for acute ischemic stroke therapies would be highly valued. We hypothesized that day-5 NIH stroke scale score (NIHSS) and day-5 diffusion weighted imaging (DWI) volume would predict clinical outcome better than either alone and could be considered as a possible surrogate outcome in early phase acute stroke trials.

Methods: The prospective Acute Stroke Accurate Prediction (ASAP) trial included a prespecified subgroup evaluated for early outcome. Logistic regression analysis was used to assess the prediction of modified Rankin (mRankin) of 0 or 1.

Results: A total of 204 subjects completed the substudy, and 116 (57%) had excellent outcome at 3 months. The area under the ROC curve (AUC) for day-5 NIHSS predicting 3-month excellent outcome was 0.84; for DWI volume predicting outcome was 0.76, and for the multivariable model combining both was 0.84.

Conclusions: The results of the early outcome substudy of the ASAP trial suggest that early stroke severity and infarct volume measures are predictive of 3-month excellent outcome. In our data set the DWI volume does not add clinically relevant information in predicting 3-month outcome. Validation of these results is required.

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Figures

Figure
Figure. Nomogram for Probability of Excellent Outcome
Simple nomogram demonstrating likelihood of excellent outcome using day 5 NIHSS score and age. The day 5 NIHSS score is determined and a vertical line up demonstrates the points earned. The age is determined and a vertical line up demonstrates the points earned for age. The sum of the two point scores is found on the total score line and a vertical line down provides the predicted probability of excellent outcome at 90 days.
See this image and copyright information in PMC

References

    1. Lees Kennedy R, Hankey Graeme J, Hacke Werner. Design of future acute-stroke treatment trials. Lancet Neurology. 2003;2:54–61. - PubMed
    1. Johnston Karen C, Wagner Douglas P, Haley EC, Jr, Connors Alfred F. Combined clinical and imaging information as an early stroke outcome measure. Stroke. 2002;33:466–472. - PMC - PubMed
    1. Higashida Randall T, Furlan AJ. Trial Design and Reporting Standards for Intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke. 2003;34:e109–e137. - PubMed
    1. Brown Devin L, Johnston Karen C, Wagner Douglas P, Haley EC., Jr Predicting major neurological improvement with intravenous recombinant tissue plasminogen activator treatment of stroke. Stroke. 2004;35:147–150. - PubMed
    1. Johnston KC, Wagner DP, Wang Xin-Qun, Newman George C, Hijs Vincent, Sen Souvik, Warach Steven for the GAIN, Citicoline and ASAP Investigators Validation of an Acute Ischemic Stroke Model. Does Diffusion-Weighted Imaging Lesion Volume Offer a Clinically Significant Improvement in Prediction of Outcome? Stroke. 2007;38:1820–1825. - PubMed

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