The main objectives of this study is to see if lipid altering therapies, independent of their mechanism of action, revers changes in the innate immune system that are induced in hyperlipidemia.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- the expression of pro-atherogenic surface markers on monocytes
- gene expression of genes involved in lipid processing
Secondary outcome
- Trans endothelial migration w
- Lipid accumulation in monocytes
- In vitro cytokine production
- Epigenetic changes
Background summary
LDL-c elicits pro-inflammatory changes in monocytes, supporting a direct
detrimental impact of LDL-c. This implies that LDL-c lowering in itself can
lower inflammation, independent of *pleiotropic* effects. Moreover,
triglyceride rich lipoproteins are associated with cardiovascular disease and
inflammation and have also been shown to activate circulating monocytes. These
data suggest direct interaction between lipids and monocytes and implies that
lipid lowering in itself can have anti-inflammatory effects, which up to date
have been solely attributed to pleiotropic effects of statins.
Study objective
The main objectives of this study is to see if lipid altering therapies,
independent of their mechanism of action, revers changes in the innate immune
system that are induced in hyperlipidemia.
Study design
This study is designed as a single center observational study. After screening
for eligibility, all subjects will undergo cardiovascular risk assessment and
laboratory testing. Thereafter monocyte phenotype (flow cytometry, gene
expression, protein expression) as well as functionality (lipid accumulation,
cytokine production, transendothelial migration).
Study burden and risks
The results of this study contribute to the understanding of the involvement of
lipid levels and the innate immune system in atherosclerosis, thereby
contributing to risk stratification in individual patients and testing of new
anti-atherosclerotic treatment. Individual subjects will gain no direct benefit
from this study. The risk of participating in this study is estimated to be
low. The patients will visit the hospital on a for medical history,
cardiovascular risk assessment and blood withdrawal in a frequency comparable
to the standard of care. Patients will be followed from start of treatment
until they reach target levels.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
patients:
- aged 18 years or older
- diagnosis of a known lipid disorder (including but not limited to hypercholestoremia, hypertriglyceridemia, combined hyperlipidemia, hypoalphalipoprotenemia, hypobetalipoprotenemia);Control group:
- Age >18 years
- No previous cardiovascular events
- No medication use
Exclusion criteria
Both groups:
- Known malignant disorders or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
- History of cardiovascular event within the last 3 months
- Clinical signs of acute infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55744.018.15 |