Arterial wall inflammation measured with 18F-FDG PET/CT in patients with familial hypercholesterolemia before and after treatment with a PCSK-9 inhibitor

Withdrawn

Conditions: arterial wall thickening
atherosclerosis
10003216

Registration Number: NL-OMON43194

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 52

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

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 (<1 month) infections and/or clinical signs of acute infection and/or CRP>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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is difference in arterial wall inflammation measured by<br /><br>18F-FDG PET/CT between patients with intermediate and severe phenotype of FH<br /><br>and the change in TBR before and after PCSK-9 inhibition in these patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are the difference in hematopoietic 18F-FDG activity in<br /><br>bone marrow before and after PCSK-9 inhibition and to evaluate whether there is<br /><br>a correlation between 18F-FDG PET activity in arterial wall and hematopoietic<br /><br>organs (i.e. bone marrow) and circulating immune cell phenotype including but<br /><br>not limited to monocytes. Furthermore we want to asses epigenetic changes<br /><br>before and after treatment. </p><br>