NCT04073797Completed
PET Imaging of Inflammation and Lipid Lowering Study
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 27 Aug 2019
- Start date
- 20 Mar 2023
- Primary completion date
- 30 May 2026
- Lead sponsor
- University of Cambridge
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT04073797
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 20 Mar 2023 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- 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
Lab values
- Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
Other
- 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
- Cardiovascular event within 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cambridge Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.