PET Imaging of Inflammation and Lipid Lowering Study

Launched by UNIVERSITY OF CAMBRIDGE · Aug 27, 2019

Keywords

ClinConnect Summary

This clinical trial, called the PET Imaging of Inflammation and Lipid Lowering Study, aims to explore how a new type of PET imaging can help measure inflammation in blood vessels related to high cholesterol levels. This study is important because traditional imaging methods have limitations that make it hard to see how well treatments are working, especially in patients with a history of heart problems. By using a special tracer that targets specific cells involved in inflammation, the researchers hope to better understand the effects of lipid-lowering therapies on vascular health.

To participate in this study, you must be over 18 years old and have certain conditions, including primary high cholesterol or a related issue, a history of cardiovascular disease, and specific findings on ultrasound related to carotid artery plaque. Participants will undergo imaging tests and will need to have their cholesterol treatments stable for at least six weeks before joining. It's also important to note that some individuals with certain medical conditions or treatments may not be eligible. If you qualify, this study could offer valuable insights into your condition and contribute to advancements in heart health.

Gender

ALL

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