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

Phase 2

Completed

Conditions: arterial wall thickening
Atherosclerosis
10003216

Registration Number: NL-OMON45376

Lead Sponsor: Vasculaire geneeskunde, Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 53

Inclusion Criteria

Patients aged 50 years or older. With Statin-associated Muscle symptoms (SAMS) and Increased cardiovascular risk with high LDL-cholesterol.

Exclusion Criteria

- Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- Chronic or recent (<1 month) infections and/ or clinical signs of acute infection and/or CRP >10
- Auto-immune diseases
- Recent or chronic immunosuppresant / antibiotic usage
- Diabetes (type 1/ type 2)
- Standard contra-indications to 18F-FDG PET/CT based on psysicians experience and current practice.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in 18F-FDG target-to-background ratio (TBR)<br /><br>following 12 weeks of PCSK-9 inhibition</p><br>

Secondary Outcome Measures

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