Imaging inflammation and cholesterol lowering in patients with cardiovascular disease
PET Imaging of Inflammation and Lipid Lowering Study
This study is testing whether a new cholesterol-lowering treatment can reduce inflammation in the arteries of people with heart disease and high cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 1 site (Cambridge) |
| Trial ID | NCT04073797 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of 68Ga-DOTATATE PET imaging to measure changes in arterial inflammation in patients with primary hypercholesterolemia or mixed dyslipidemia who have stable cardiovascular disease. Participants will be randomly assigned to receive either inclisiran or colchicine, alongside carotid artery imaging using PET-MRI and a novel ultrasound method for plaque analysis. The goal is to determine the effectiveness of these treatments in reducing vascular inflammation and improving cholesterol levels.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary hypercholesterolemia or mixed dyslipidemia, a history of cardiovascular disease, and elevated LDL cholesterol despite maximum tolerated lipid-lowering therapies.
Not a fit: Patients who are not eligible include those with contraindications to MRI, women of childbearing potential not using contraception, and those already taking inclisiran or colchicine.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing and treating vascular inflammation in patients with high cholesterol and cardiovascular disease.
How similar studies have performed: Previous studies have shown promise in using novel imaging techniques for assessing vascular inflammation, but this specific approach with SST2 PET imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cambridge
- University of Cambridge — Cambridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Jason M Tarkin, MBBS PhD — University of Cambridge
- Study coordinator: Jason M Tarkin, MBBS PhD
- Email: jt545@cam.ac.uk
- Phone: +44(0)1223331504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.