Since high cholesterol is a major riskfactor for cardiovascular disease we will select patients with inhirated elevated cholesterol (familial hypercholesterolemia. We want to evaluate the long term effect of cholesterol lowering treatment on the…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study we want to evaluate the long term effect of cholesterol lowering
treatment (1year) on the circulating innate immune cell in patietns with
familial hypercholesterolemia. This most important question is if long term
treatment can effect the trained immunity phenotype.
Secondary outcome
nvt
Background summary
Cardiovascular disease accounts for more than 2.5 million deaths each year.
Previous research has shown the prominent role of white bloodcells, that form a
part of our immune system, in cardiovascular disease. These cells are prone for
inflammation which promotes atherosclerosis.
Study objective
Since high cholesterol is a major riskfactor for cardiovascular disease we will
select patients with inhirated elevated cholesterol (familial
hypercholesterolemia. We want to evaluate the long term effect of cholesterol
lowering treatment on the increased pro inflammatory response by their white
blood cells.
Study design
This is an observationeel multi center study
Study burden and risks
There is no direct benefit to the study participants. The risks for
participants are overall negligible, except for possible discomfort
related to the venepuncture. After signing for informed consent, blood will be
drawn, followed by 3months and 12 months timepoint.
The healthy volunteers will only have one time point blooddraw at the beginning
of the study.
The blooddraw doesn*t impose a risk for the participants, other than a possible
hematoma at the puncture site.
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Aged 18 years or older
- They are eligible for participation if they fulfil the criteria for
*possible* FH (3-5 points), *probable* FH (6-8 points) or *definitive* FH (>8
points), according to the Dutch Lipid Clinic Network diagnostic criteria for
familial hypercholesterolemia and untreated LDL levels >4.9 mmol/l and
requiring lipid lowering treatment according to the treating physician
- No previous cardiovascular events
- Written informed consent
Control subjects:
- Age 18 years or older
- LDL cholesterol <3.5 mmol/l
- No previous cardiovascular events
- Written informed consent
Exclusion criteria
- Current lipid lowering treatment or treatment with lipid lowering drugs in
the past year.
- Age <18 years
- Inability to personally provide written informed consent (e.g. for linguistic
or mental reasons)
- Current treatment for maliganancy
- Acute or chronic infections with fever at the time of participation
- Medical history of any disease associated with immune deficiency (either
congenital or acquired, including chemotherapy, chronic steroid use, organ
transplant)
- Clinically significant infections within 1 months prior to study entry
(defined as fever >38.5)
- Previous vaccination within 1 months prior to study entry
- Chronic use of anti-inflammatory drugs such as NSAIDs (acetylsalicylic acid
<100 mg/day excluded
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 | NL72155.091.20 |