Actively Recruiting
PET Imaging of Inflammation and Lipid Lowering Study
Led by University of Cambridge · Updated on 2024-07-19
63
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
C
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PET Imaging of Inflammation and Lipid Lowering Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants older than 18 years
- Able to give written, informed consent and lie flat during imaging
- Have primary hypercholesterolemia (non-familial or familial) or mixed dyslipidemia
- History of cardiovascular disease such as acute coronary syndrome, coronary revascularisation, ischemic stroke, or peripheral arterial disease
- LDL cholesterol 2.6 mmol/L or higher despite maximum tolerated statins with or without other lipid-lowering therapies
- Lipid-lowering therapy unchanged for at least 6 weeks before screening
- Existing carotid atherosclerotic plaque 15 mm or larger by ultrasound
You will not qualify if you...
- Women of childbearing potential not using adequate contraception
- Contraindication to MRI scanning
- Statin-associated muscle inflammation or liver function abnormalities
- Currently taking inclisiran or colchicine
- Sensitivity or contraindication to inclisiran or colchicine, including severe liver or kidney impairment, blood disorders, or use of interacting medications
- Allergy to contrast agents or contrast-induced kidney issues
- Chronic kidney disease with eGFR below 30 mL/min/1.73 m2
- Cardiovascular event within the last 6 months
- Any medical condition preventing lying flat or participation
- Uncontrolled chronic inflammatory disorders
- Recent relevant cancer
- Treatment with drugs causing significant interactions with study medications
- Use of systemic corticosteroids or immunosuppressive drugs
- Previous or planned carotid endarterectomy or stenting on the study side
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Cambridge
Cambridge, United Kingdom
Actively Recruiting
Research Team
J
Jason M Tarkin, MBBS PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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