About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Inclisiran
- 68Ga-DOTATATE PET-MRI
- Colchicine
Treatment groups
Sponsors and collaborators
University of Cambridge
Lead sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Wellcome Trust
Collaborator
GE Healthcare
Collaborator
Lund University
Collaborator