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 language | English (US) |
|---|---|
| Pages (from-to) | 293-298 |
| Number of pages | 6 |
| Journal | Stroke |
| Volume | 30 |
| Issue number | 2 |
| State | Published - Feb 1999 |
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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
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 journal › Article
}
TY - JOUR
T1 - Infarct volume as a surrogate or auxiliary outcome measure in ischemic stroke clinical trials
AU - Saver, Jeffrey L.
AU - Johnston, Karen C.
AU - Homer, Daniel
AU - Wityk, Robert
AU - Koroshetz, Walter
AU - Truskowski, Laura L.
AU - Haley, E. Clarke
PY - 1999/2
Y1 - 1999/2
N2 - 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.
AB - 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.
KW - Cerebral infarction
KW - Clinical trials
KW - Stroke assessment
KW - Stroke outcome
KW - Tomography, x-ray computed
UR - http://www.scopus.com/inward/record.url?scp=0032961564&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032961564&partnerID=8YFLogxK
M3 - Article
C2 - 9933262
AN - SCOPUS:0032961564
VL - 30
SP - 293
EP - 298
JO - Stroke
JF - Stroke
SN - 0039-2499
IS - 2
ER -