Status:
RECRUITING
PET Imaging of Inflammation and Lipid Lowering Study
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Wellcome Trust
Conditions:
Hypercholesterolemia
Hypercholesterolemia, Familial
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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, it...
Detailed Description
Up-regulation of SST2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68Ga-DOTATATE. To test...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Sensitivity and/or contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood disorders, and patients with renal or hepatic impairment who are taking a P-gp inhibitor or a strong CYP3A4 inhibitor
- 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 medications
- Current use of systemic corticosteroids or other immunosuppressive drugs
- Previous or planned carotid endarterectomy surgery or stenting on the index side
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04073797
Start Date
March 20 2023
End Date
March 1 2026
Last Update
July 19 2024
Active Locations (1)
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1
University of Cambridge
Cambridge, United Kingdom