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

Stroke

Volumn 30, Issue 2, 1999, Pages 293-298

  Saver, Jeffrey L ^a   Johnston, Karen C ^b   Homer, Daniel ^c   Wityk, Robert ^d   Koroshetz, Walter ^e   Truskowski, Laura L ^b   Haley, E Clarke ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

Author keywords

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

Indexed keywords

TIRILAZAD;

ADULT; AGED; ARTICLE; BRAIN INFARCTION; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STROKE; TREATMENT OUTCOME;

EID: 0032961564     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.STR.30.2.293     Document Type: Article

References (33)

1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125:605-613.
2. Temple RJ. A regulatory authority's opinion about surrogate endpoints. In: Nimmo WS, Tucker GT, eds. Clinical Measurement in Drug Evaluation. New York, NY: John Wiley & Sons Inc; 1995.
3. Prentice RL Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 1989;8:431-440.
4. Boissel J-P, Collet J-P, Moleur P, Haugh M. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol. 1992;43:235-244.
5. Brass LM. Trial designs issues: endpoints and sample size. Cerebrovasc Dis. 1995;5(suppl 1):3-11.
6. Fleming TR, Prentice RL, Pepe MS, Glidden D. Surrogate and auxiliary endpoints in clinical trials, with potential applications in cancer and AIDS research. Stat Med. 1994;13:955-968.
7. Brott T, Adams HP, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, Rorick M, Moomaw CJ, Walker M. Developing measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864-870.
8. Brott T, Marler JR, Olinger CP, Adams HP, Tomsick T, Barsan WG, Biller J, Eberle R, Hertzberg V, Walker M. Measurements of acute cerebral infarction: lesion size by computed tomography. Stroke. 1989; 20:871-875.
9. Chua MC, Davis SM, Infeld B, Rossiter SC, Tress BM, Hopper JL. Prediction of functional outcome and tissue loss in acute cortical infarction. Arch Neurol. 1995;52:496-500.
10. The RANTTAS Investigators. A Randomized Trial of Tirilazad Mesylate in Patients With Acute Stroke (RANTTAS). Stroke. 1996;27:1453-1458.
11. Lyden P, Brott T, Tilley B, Welch KM, Mascha EJ, Levine S, Haley EC, Grotta J, Marler J. Improved reliability of the NIH Stroke Scale using video training. Stroke. 1994;25:2220-2226.
12. Mahoney F, Barthel D. Functional evaluation: the Barthel Index. Md Med J. 1965;2:61-65.
13. Jennett B, Bond M. Assessment of outcome after severe brain damage: a practical scale. Lancet. 1975;1:480-484.
14. NINDS rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
15. Conover WJ. Practical Nonparametric Statistics. New York, NY: John Wiley & Sons Inc; 1980.
16. Hosmer DW, Lemeshow S. Applied Logistic Regression. New York, NY: John Wiley & Sons Inc; 1989.
17. Lyden PD, Zweifler R, Mahdavi Z, Lonzo L. A rapid, reliable, and valid method for measuring infarct and brain compartment volumes from computed tomographic scans. Stroke. 1994;25:2421-2428.
18. Streifler JY, Beloosesky Y, Grinblat Y. Infarct size and functional recovery do not always correlate: a brain CT study in acute stroke patients. Neurology. 1995;45(suppl 4):A331. Abstract.
19. Olsen TS. Outcome following occlusion of the middle cerebral artery. Acta Neurol Scand. 1991;83:254-258.
20. Finocchi C, Gandolfo C, Gasparetto B, Del Sette M, Croce R, Loeb C. Value of early variables as predictors of short-term outcome in patients with acute focal cerebral ischemia. Ital J Neurol Sci. 1996;17:341-346.
21. Naeser MA, Hayward RW, Laughlin SA, Zata LM. Quantitative CT scan studies in aphasia, I: infarct size and CT numbers. Brain Lang. 1981;12: 140-164.
22. Paty DW, Li DK, UBC MS/MRI Study Group, IFB MS Study Group. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis, II: MRI analysis results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993;43:662-667.
23. Miller DH, Albert PS, Barkhof F, Francis G, Frank JA, Hodgkinson S, Lublin FD, Paty DW, Reingold SC, Simon J. Guidelines for the use of magnetic resonance techniques in monitoring the treatment of multiple sclerosis. Ann Neurol. 1996;39:6-16.
24. Jongbloed L. Prediction of function after stroke: a critical review. Stroke. 1986;17:765-776.
25. Goldstein LB, for the Sygen in Acute Stroke Study Investigators. Common drugs may influence motor recovery after stroke. Neurology. 1995;45:865-871.
26. Chamorro A, Vila N, Ascaso C, Saiz A, Montalvo J, Alonso P, Tolosa E. Early prediction of stroke severity: role of the erythrocyte sedimentation rate. Stroke. 1995;26:573-576.
27. Lindgren A, Norvving B, Rudling O, Johansson BB. Comparison of clinical and neuroradiological findings in first-ever stroke. Stroke. 1994; 25:1371-1377.
28. Bryan RN, Levy LM, Whitlow WD, Killian JM, Preziosi TJ, Rosario JA. Diagnosis of acute cerebral infarction: comparison of CT and MR imaging. AJNR Am J Neuroradiol. 1991;12:611-620.
29. Tatemichi TK, Mohr JP, Rubinstein LV, Kase CS, Nichols FT, Price TR, Wolf PA. CT findings and clinical course in acute stroke: the NINCDS Pilot Stroke Data Bank. Stroke. 1985;16:138.
30. Skriver EB, Olsen TS. Transient disappearance of cerebral infarcts on CT scan: the so-called fogging effect. Neuroradiology. 1981;22:61-65.
31. Lovblad K-O, Baird AE, Schlaug G, Benfield A, Siewert B, Voetsch B, Connor A, Burzynski C, Edelman R, Warach S. Ischemic lesion volumes in acute stroke by diffusion-weighted magnetic resonance imaging correlate with clinical outcome. Ann Neurol. 1997;42:164-170.
32. Warach S, Dashe JF, Edelman RR. Clinical outcome in ischemic stroke predicted by early diffusion-weighted and perfusion magnetic resonance imaging: a preliminary analysis. J Cereb Blood Flow Metab. 1996;16: 53-59.
33. Warach S, Benfield A, Schlaug G, Siewert B, Edelman RR. Reduction of lesion volume in human stroke by citicoline detected by diffusion weighted magnetic resonance imaging: a pilot study. Ann Neurol. 1996; 40:527.