Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials

Jeffrey L. Saver, Karen C. Johnston, Daniel Homer, Robert Wityk, Walter Koroshetz, Laura L. Truskowski, E. Clarke Haley

Research output: Contribution to journalArticle

Abstract

Background and Purpose - Reduction in infarct volume is the standard measure of therapeutic success in animal stroke models. Reduction in infarct volume has been advocated as a biological surrogate or auxiliary outcome measure for human stroke clinical trials to replace or supplement deficit, disability, and global clinical scales. However, few studies have investigated correlations between infarct volume and clinical end points in acute ischemic stroke patients. Methods - CT scans at days 6 to 11 were acquired prospectively in 191 fully eligible patients enrolled in the Randomized Trial of Tirilazad Mesylate in Patients With Acute Stroke (RANTTAS). Patients were enrolled within 6 hours of onset of stroke in any vessel distribution. Infarct volume was measured by operator-assisted computerized planimetry. Results - One hundred thirty-two patients had visible new supratentorial infarcts, with median infarct volume of 28.0 cm3 (interquartile range, 9.0 to 93.0 cm3). Fifty-nine patients had no visible new infarct. Correlations with standard 3-month outcome scales and mortality were as follows: Barthel Index, r=0.43; Glasgow Outcome Scale, r=0.53; National Institutes of Health Stroke Scale, r= 0.54; mortality, r=0.31. For visible infarcts alone, correlations were as follows: BI, r=0.46; GOS, r=0.59; NIHSS, r=0.56; mortality, r=0.32. Conclusions - Subacute CT infarct volume correlates moderately with 3-month clinical outcome as assessed by widely used neurological and functional assessment scales. The modesty of this linkage constrains the use of infarct volume as a surrogate end point in ischemic stroke clinical trials.

Original languageEnglish (US)
Pages (from-to)293-298
Number of pages6
JournalStroke
Volume30
Issue number2
StatePublished - Feb 1999

Fingerprint

Stroke
Outcome Assessment (Health Care)
Clinical Trials
Mortality
Glasgow Outcome Scale
Cone-Beam Computed Tomography
National Institutes of Health (U.S.)
Animal Models
Biomarkers
Therapeutics

Keywords

  • Cerebral infarction
  • Clinical trials
  • Stroke assessment
  • Stroke outcome
  • Tomography, x-ray computed

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Neuroscience(all)

Cite this

Saver, J. L., Johnston, K. C., Homer, D., Wityk, R., Koroshetz, W., Truskowski, L. L., & Haley, E. C. (1999). Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. Stroke, 30(2), 293-298.

Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. / Saver, Jeffrey L.; Johnston, Karen C.; Homer, Daniel; Wityk, Robert; Koroshetz, Walter; Truskowski, Laura L.; Haley, E. Clarke.

In: Stroke, Vol. 30, No. 2, 02.1999, p. 293-298.

Research output: Contribution to journalArticle

Saver, JL, Johnston, KC, Homer, D, Wityk, R, Koroshetz, W, Truskowski, LL & Haley, EC 1999, 'Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials', Stroke, vol. 30, no. 2, pp. 293-298.
Saver JL, Johnston KC, Homer D, Wityk R, Koroshetz W, Truskowski LL et al. Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. Stroke. 1999 Feb;30(2):293-298.
Saver, Jeffrey L. ; Johnston, Karen C. ; Homer, Daniel ; Wityk, Robert ; Koroshetz, Walter ; Truskowski, Laura L. ; Haley, E. Clarke. / Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials. In: Stroke. 1999 ; Vol. 30, No. 2. pp. 293-298.
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