Remnant cholesterol: the missing lipid

Completed

• Conditions: arterial wall thickening; atherosclerosis; 10003216

• Registration Number: NL-OMON41840
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Subjects with diagnosis of Familial dysbetalipoproteinemia (type III hyperlipoproteinemia)
- Aged 50 years or older
- No treatment with lipid lowering drugs or willing to stop lipid lowering therapy for 6 weeks prior to baseline measurements

Exclusion Criteria

1 . Malignant diseases or any other clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator
2 . Standard contra-indications to MRI and 18F-FDG PET/CT based on physicians experience and current practices: Claustrophobia, metal in the body, as a result of e.g. osteosynthetic material, pacemaker implantation of artificial cardiac valves.
3. Clinical signs of acute infection and/or CRP > 10
4 . Participation in a scientific study with radiation exposure in the year prior to inclusion or
planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons
5. Recent (< 1 month prior to screening) or current treatment with medications that
may have a significant effect on plaque inflammation, including: oral, rectal, or injectable corticosteroids or immunosuppressive medications
6. Use of lipid lowering drugs in the last 6 weeks prior to baseline measurements
7. Cardiovascular event in the last 3 months prior to baseline measurements

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are arterial wall inflammation (target-to-background<br /><br>ratio) measured by 18F-FDG PET/CT and vessel wall dimensions measured by MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Trans endothelial migration (TEM) of monocytes<br /><br>- Monocyte subtyping by FACS analysis using a CD14, CD16 and HLA-DR backbone.<br /><br>- In vitro cytokine production by using isolated monocytes of subjects.<br /><br>- Epigenetic changes in genes identified with FACS or in vitro stimulation<br /><br>assays. </p><br>