Background
Methods/design
Aim
Study design
Patient eligibility and recruitment
Study procedures
Inclusion and exclusion criteria
Outcomes
Primary endpoint
Primary endpoint |
Change in PMR in the primary lesion measured by CMR imaging |
Secondary endpoint |
Change in PMR in all lesions measured by CMR imaging Percentage change in PMR in the primary lesion measured by CMR imaging Percentage change in PMR in all lesion measured by CMR imaging Changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by CTA Changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by CTA Percentage changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by CTA Percentage changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by CTA |
Other endpoint |
Changes and percentage changes in triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, VLDL-cholesterol, remnant-like cholesterol, LPL activity, and high-sensitivity C-reactive protein Changes and percentage changes in small, dense LDL and mean LDL particle diameter Changes and percentage changes in EPA, DHA, AA, EPA/AA ratio, and omega-3 index (weight percentage of eicosapentaenoic acid [EPA, C20:5ω3] and docosahexaenoic acid [DHA, C20:6ω3] in total fatty acids out of all lipids) Changes and percentage changes in leptin and adiponectin |
Secondary endpoint
Other variables
Sample size
Randomization
Allocation factors
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Age at the time of consent: younger than 65 years/65 years or older
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Gender: male/female
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Concomitant type II diabetes: present/absent