PET Imaging of Inflammation and Lipid Lowering Study
Trial Parameters
Brief Summary
While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.
Eligibility Criteria
Inclusion Criteria: * Male or female participants \>18 years old * Able to give written, informed consent and to lie flat * Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and * History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and * Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and * Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound Exclusion Criteria: * Women of childbearing potential not using adequate contraception * Contra-indication to MRI scanning * Statin-associated myositis or liver function abnormality * Already taking inclisiran or colchicine * Sensitivity an