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Magnetic resonance imaging (MRI) detects significant changes in the morphology of atherosclerotic plaque during the course of lipid-lowering therapy, and demonstrates the promise of this noninvasive imaging modality for use in clinical trials. Images obtained from the placebo-control arm of a five-site carotid MRI study were analyzed to assess the variability of MRI for measuring lesion size and composition, and to provide sample size calculations for a variety of imaging endpoints. MRI is capable of quantifying atherosclerotic lesion size and plaque composition in the setting of a multicenter trial with low interscan variability. Sample-size calculations based on reproducibility data for carotid MRI indicate that clinical trials involving approximately 150 subjects per treatment arm would be sufficiently powered to detect a 5% difference in treatment effect. MRI may provide valuable insight into pathophysiology and mechanisms of pharmacologic activity.
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