PET Imaging of Inflammation and Lipid Lowering Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Cambridge

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

63 Participants
are divided into 3 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