MRI Screening for Lipid-Rich Necrotic Core in Multicenter Clinical Trials of Lipid-Lowering Therapy

Niranjan Balu¹, Daniel S. Hippe¹, Jie Sun¹, Dongxiang Xu¹, Thomas Hatsukami², Chun Yuan¹

The size of the lipid-rich necrotic core (LRNC) in atherosclerotic plaque is an early indicator of efficacy in lipid lowering therapy. Clinical trials using LRNC as the primary endpoint require highly specific screening for subjects with LRNC in order to be cost-effective. We describe the first multicenter MRI study using LRNC as the primary study endpoint with a tiered ultrasound-MRI screening. A probabilistic model derived using sensitivity and specificity of maximum wall thickness (maxWT) in detecting subjects with LRNC shows that total imaging costs can be reduced by 10% while increasing specificity by adding maxWT to the tiered ultrasound-MRI screening.