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1 results

  • 33 - Monitoring of pharmaceutical interventions: MR plaque imaging

  • from Monitoring pharmaceutical interventions
  • Edited by Jonathan Gillard, University of Cambridge, Martin Graves, University of Cambridge, Thomas Hatsukami, University of Washington, Chun Yuan, University of Washington
  • Book:
    Carotid Disease
    Published online:
    03 December 2009
    Print publication:
    07 December 2006, pp 464-470

  • Summary

    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.