PET Imaging of Inflammation and Lipid Lowering Study

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cambridge
• Collaborators: Cambridge University Hospitals NHS Foundation Trust; Wellcome Trust
• Treatments: Evolocumab

Criteria

Inclusion Criteria:

• Male or female participants >18 years old

• Able to give written, informed consent and to lie flat

• Have a history of CVD (acute coronary syndrome, ischaemic stroke, transient ischaemic attack, or documented coronary, carotid, or peripheral arterial disease) and elevated LDL cholesterol despite high-intensity atorvastatin (Group 1), or

• Have HeFH (definite or probable FH based on clinical criteria) and elevated LDL cholesterol despite high-intensity atorvastatin (Group 2)

• Lipid lowering therapy unchanged for at least 6 weeks prior to screening

Exclusion Criteria:

• Women of child bearing potential not using adequate contraception

• Contra-indication to MRI scanning

• Statin-associated myositis or liver function abnormality

• Sensitivity to PCSK9 inhibitors or monoclonal antibodies

• Contrast allergy or contrast-nephropathy

• Chronic kidney disease (eGFR <30 mL/min/1.73 m2)

• Cardiovascular event within 6 months

• Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study

• Uncontrolled chronic inflammatory disorder

• History of recent malignancy deemed relevant to the study by the investigator

• Treatment with medications that result in significant drug to drug interactions with the study medication

• Current use of systemic corticosteroids

• Previous carotid endarterectomy surgery or stenting