PET Imaging of Inflammation and Lipid Lowering Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
University of Cambridge
RECRUITING
Cambridge
Contact Information
Primary
Jason M Tarkin, MBBS PhD
jt545@cam.ac.uk
+44(0)1223331504
Time Frame
Start Date: 2023-03-20
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 63
Treatments
Experimental: Stable CVD - treatment
Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to add on therapy with inclisiran + placebo tablet
Active_comparator: Stable CVD - placebo control
Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + colchicine tablet
Placebo_comparator: HeFH - treatment
Stable CVD with LDL ≥2.6 despite maximally tolerated statins ± other lipid lowering therapies, randomised to placebo injection + placebo tablet
Sponsors
Collaborators: GE Healthcare, Wellcome Trust, Cambridge University Hospitals NHS Foundation Trust, Lund University
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov