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Published online before print April 4, 2007, doi:10.1212/01.wnl.0000261488.05906.c1)
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 Volume 68, Number 24, June 12, 2007
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NEUROLOGY 2007;68:2099-2106
© 2007 American Academy of Neurology

The Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) Trial

E. Feldmann, MD, J. L. Wilterdink, MD, A. Kosinski, PhD, M. Lynn, MS, M. I. Chimowitz, MB, ChB, J. Sarafin, RN, H. H. Smith, RN, F. Nichols, MD, J. Rogg, MD, H. J. Cloft, MD, PhD, L. Wechsler, MD, J. Saver, MD, S. R. Levine, MD, C. Tegeler, MD, R. Adams, MD, M. Sloan, MD and The Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) Trial Investigators*

Address correspondence and reprint requests to Dr. Edward Feldmann Department of Clinical Neurosciences, Brown University School of Medicine, 110 Lockwood Street, Suite 324, Providence, RI 02903 EFeldmann{at}lifespan.org

Background: Transcranial Doppler ultrasound (TCD) and magnetic resonance angiography (MRA) can identify intracranial atherosclerosis but have not been rigorously validated against the gold standard, catheter angiography. The WASID trial (Warfarin Aspirin Symptomatic Intracranial Disease) required performance of angiography to verify the presence of intracranial stenosis, allowing for prospective evaluation of TCD and MRA. The aims of Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) trial were to define abnormalities on TCD/MRA to see how well they identify 50 to 99% intracranial stenosis of large proximal arteries on catheter angiography.

Study Design: SONIA standardized the performance and interpretation of TCD, MRA, and angiography. Study-wide cutpoints defining positive TCD/MRA were used. Hard copy TCD/MRA were centrally read, blind to the results of angiography.

Results: SONIA enrolled 407 patients at 46 sites in the United States. For prospectively tested noninvasive test cutpoints, positive predictive values (PPVs) and negative predictive values (NPVs) were TCD, PPV 36% (95% CI: 27 to 46); NPV, 86% (95% CI: 81 to 89); MRA, PPV 59% (95% CI: 54 to 65); NPV, 91% (95% CI: 89 to 93). For cutpoints modified to maximize PPV, they were TCD, PPV 50% (95% CI: 36 to 64), NPV 85% (95% CI: 81 to 88); MRA PPV 66% (95% CI: 58 to 73), NPV 87% (95% CI: 85 to 89). For each test, a characteristic performance curve showing how the predictive values vary with a changing test cutpoint was obtained.

Conclusions: Both transcranial Doppler ultrasound and magnetic resonance angiography noninvasively identify 50 to 99% intracranial large vessel stenoses with substantial negative predictive value. The Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis trial methods allow transcranial Doppler ultrasound and magnetic resonance angiography to reliably exclude the presence of intracranial stenosis. Abnormal findings on transcranial Doppler ultrasound or magnetic resonance angiography require a confirmatory test such as angiography to reliably identify stenosis.

Editorial, see page 2057

Supplemental data at www.neurology.org

This article was previously published in electronic format as an Expedited E-Pub on April 4, 2007, at www.neurology.org.

*See appendix E-1 for list of investigators.

Funded by a research grant (1 RO1 NS 39131-04) from the US Public Health Service National Institute of Neurological Disorders and Stroke (NINDS).

Disclosure: The authors report no conflicts of interest.

Received July 21, 2006. Accepted in final form February 15, 2007.


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