arterial wall thickening atherosclerosis
Conditions
Interventions
alirocumab for 3 months
atherosclerosis
familial hypercholesterolemia
PCSK9 inhibition
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: patients with: Aged 50 years or older Familial hypercholesterolemia intermediate or severe genotype Elevated LDL levels prior to start treatment No previous cardiovascular events No treatment with a PCSK9 inhibitor or willing to stop with the treatment for 6 weeks prior to baseline measurements
Exclusion criteria
Exclusion criteria: 1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. 2. Chronic or recent (10 3. Auto-immune diseases 4. Recent or chronic immunosuppressant or antibiotic usage 5. Type I or II diabetes mellitus 6. Standard contra-indications to 18F-FDG PET/CT based on physicians experience and current practices;Control group: * A history of cardiovascular disease * A known elevated risk factor for cardiovascular disease * Use of any cardiovascular medication, including but not limited to lipid-lowering therapy, antihypertensive drugs, antidiabetic drugs, platelet aggregation inhibitors and anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is difference in arterial wall inflammation measured by 18F-FDG PET/CT between patients with intermediate and severe phenotype of FH and the change in TBR before and after PCSK-9 inhibition in these patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the difference in hematopoietic 18F-FDG activity in bone marrow before and after PCSK-9 inhibition and to evaluate whether there is a correlation between 18F-FDG PET activity in arterial wall and hematopoietic organs (i.e. bone marrow) and circulating immune cell phenotype including but not limited to monocytes. Furthermore we want to asses epigenetic changes before and after treatment. | — |
Countries
The Netherlands
Outcome results
None listed