Original ArticleValidating Imaging Biomarkers of Cerebral Edema in Patients With Severe Ischemic Stroke
Section snippets
Patient Selection
EPITHET was a phase II, prospective, randomized controlled trial of acute ischemic stroke patients who were treated with intravenous tissue plasminogen activator (IV tPA) or placebo between 3 and 6 hours after stroke onset and underwent serial MRI both before and 3 to 5 days after treatment and at 90 days. Patients were excluded if baseline noncontrast CT revealed intracranial hemorrhage or major early ischemic change (i.e., more than one-third of the MCA territory). The full methodology of
Baseline Demographics and Outcomes
Baseline demographics and outcomes are shown in Table 1. Of the 12 patients who met study criteria, the average age was 70.8 years (range 41-86 years); the median baseline NIHSS score was 18.5 (range 10-25). There were 4 (33.3%) females. Seven (58.3%) strokes involved the right hemisphere. The mean time from symptom discovery to baseline MRI was 231 minutes (range 142-320) minutes. The average baseline DWI lesion size was 137.7 cm3 (range 88.2-196.7 cm3).
Six (50%) patients received IV tPA. The
Discussion
Our findings show that within the first 3 to 5 days of severe hemispheric stroke onset, volumes of the cerebral hemisphere and lateral ventricle determined using MRI change in a manner consistent with edema formation. Specifically, there is significant growth in hemisphere volume and significant reduction in ventricular volume over time. Importantly, these measurements demonstrate excellent interrater agreement. In addition, we have shown that increases in hemisphere volume are predictive of
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2016, The Lancet NeurologyCitation Excerpt :All imaging data were sent to a core laboratory (Yale University, New Haven, CT, USA) (GKS and LAB) for measurement of surrogate imaging measures of brain oedema (GKS and LAB)—ie, midline shift, change in hemisphere volume, and lesional swelling volume. Imaging measures were ascertained on baseline and follow-up scans with Analyze software (version 11.0) by the masked imaging core based on previous methods.19–21 Previous inter-rater analyses have shown a concordance correlation of greater than or equal to 0·94.19
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Drs. Yoo and Sheth contributed equally to this article.