NCT04073797 PET Imaging of Inflammation and Lipid Lowering Study
| NCT ID | NCT04073797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cambridge |
| Condition | Hypercholesterolemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2023-03-20 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jason M Tarkin, MBBS PhD
PRINCIPAL INVESTIGATOR
University of Cambridge
Frequently Asked Questions
Who can join the NCT04073797 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04073797 currently recruiting?
Yes, NCT04073797 is actively recruiting participants. Contact the research team at jt545@cam.ac.uk for enrollment information.
Where is the NCT04073797 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT04073797 clinical trial?
NCT04073797 is sponsored by University of Cambridge. The principal investigator is Jason M Tarkin, MBBS PhD at University of Cambridge. The trial plans to enroll 63 participants.