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dal-PLAQUE study: Hope for CETP inhibition?
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Utility of atherosclerosis imaging in the evaluation of drug therapies
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dal-PLAQUE - Background
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Initial Experience with CETPi
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Erik SG Stroes & Diederik F van Wijk Lancet 2011; 378: 1529-1530
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Lipid – Efficacy (% change from baseline)
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dal-PLAQUE - Rationale
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Why MRI & FDG-PET?
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Measuring atherosclerosis MRI
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MRI - Logistics
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Niacin MRI regression - Oxford study
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Niacin MRI Regression - Oxford Study
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Measuring atherosclerosis PET/CT
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FDG-PET/CT scan reproducibility
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Evaluating 18F-FDG-PET images of atherosclerosis
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PET indices derived from the regions of interest (ROI)
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Attenuation of plaque inflammation by simvastatin by 18FDG PET/CT @ 3 months
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dal-PLAQUE study design and timeline of imaging assessments
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dal-PLAQUE Sites: Multicenter FDG-PET & MRI Study
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dal-PLAQUE - Key Inclusion Criteria
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dal-PLAQUE - Predefined Endpoints
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Baseline characteristics (Intent-to-Treat [ITT]) - Demography and CHD risk factors
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Baseline characteristics (ITT) - Plasma lipid profile
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Mean change from baseline in plaque burden at 24 Months (MRI) and inflammation at 6 Months (PET/CT)
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Summary of MRI & PET endpoints
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Sample MRI Images from a patient at baseline and treated with dalcetrapib 600 mg for 24 Months showing regression in Total Vessel Area (TVA)
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Raw mean data limited to subjects that provided imaging data for all MRI imaging time points
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MRI Lumen Area – average carotid (ITT) No change with dalcetrapib vs significant increase with placebo
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Raw mean data limited to subjects that provided imaging data for all PET imaging time points
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Association between HDL-C and arterial inflammation as measured by MDS TBR on PET/CT
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Association between atherosclerotic burden (TVA on MRI) and arterial inflammation (MDS TBR on FDG-PET/CT)
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Changes in lipids, lipoproteins, and hs-CRP during the study period
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Inflammatory Markers: Change from Baseline to 24 Months
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Safety variables
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dal-PLAQUE – Overall conclusions
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