Published Online
on August 4, 2005

A more recent version of this article appeared on September 1, 2005

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Submitted on September 10, 2004
Revised on November 2, 2004
Accepted on November 26, 2004

3D Ultrasound Measurement of Change in Carotid Plaque Volume. A Tool for Rapid Evaluation of New Therapies

Craig D. Ainsworth MD; Christopher C. Blake MSc; Arturo Tamayo MD; Vadim Beletsky MD; Aaron Fenster PhD; and J. David Spence MD^*

From the Stroke Prevention and Atherosclerosis Research Centre (C.D.A., A.T., V.B., J.D.S.) and Imaging Research Laboratories (C.C.B., V.B., A.F., J.D.S.), Robarts Research Institute, London, Canada.

^* To whom correspondence should be addressed. E-mail: dspence{at}robarts.ca.

Background and Purpose--New therapies are being developed that are antiatherosclerotic but that lack intermediate end points, such as changes in plasma lipids, which can be measured to test efficacy. To study such treatments, it will be necessary to directly measure changes in atherosclerosis. The study was designed to determine sample sizes needed to detect effects of treatment using 3D ultrasound (US) measurement of carotid plaque.

Methods--In 38 patients with carotid stenosis >60%, age±SD 69.42±7.87 years, 15 female, randomly assigned in a double-blind fashion to 80 mg atorvastatin daily (n=17) versus placebo (n=21), we measured 3D plaque volume at baseline and after 3 months by disc segmentation of voxels representing carotid artery plaque, after 3D reconstruction of parallel transverse duplex US scans into volumetric 3D data sets.

Results--There were no significant differences in baseline risk factors. The rate of progression was 16.81±74.10 mm³ in patients taking placebo versus regression of -90.25±85.12 mm³ in patients taking atorvastatin (P<0.0001)

Conclusions--3D plaque volume measurement can show large effects of therapy on atherosclerosis in 3 months in sample sizes of 20 patients per group. Sample sizes of 22 per group would be sufficient to show an effect size of 25% that of atorvastatin in 6 months. This technology promises to be very useful in evaluation of new therapies.

Key words: atherosclerosis • carotid artery plaque • ultrasonography

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