To organize one pool of control subjects for IMT studies.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Several parameters will be measured among which the most important ones are:
IMT, Achilles tendon (AT) thickness, lipid profile and other standard
biochemistry and haematology parameters. Subjects will also undergo a general
physical exam. Blood samples will be stored for future parameters related to
cardiovascular disease which are specific for future studies.
Secondary outcome
Not applicable.
Background summary
The intima media thickness (IMT) is considered a validated surrogate end point
for the status of atherosclerosis as well as present and future vascular risk.
It is increasingly measured in human studies as a surrogate end point for
cardiovascular risk. In many trials, the mean IMT of certain patient groups is
compared to that of a control group in order to assess the risk. This protocol
describes a study in which one control population will be assembled to avoid
overlap in work for several studies.
Study objective
To organize one pool of control subjects for IMT studies.
Study design
A cross-sectional study, and the subjects will visit the hospital only once for
this study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Subjects will have to visit the hospital only
once, during which IMT and AT thickness will be measured by means of
ultrasonography, a simple and non-invasive imaging technique. Furthermore, one
blood sample of 80 mL will be taken, and subjects will undergo a physical exam.
We consider the risks negligible and the burden minimal.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- male and females, aged 18-75 y
- subjects must be willing and able to give written informed consent
Exclusion criteria
- Any lipid disorder, including familial hypercholesterolemia (FH), familial defective apolipoprotein B (FDB), familial combined hypercholesterolemia (FCH) or another primary dyslipidemia;
- Subjects of whom an IMT cannot be properly measured, due to e.g. neck/throat surgery;
- BMI > 35 kg/m2;
- Subjects who drink alcohol excessively defined as more than 21 units/wk;
- Any clinical significant medical condition that could interfere with being a control participant.
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 | NL18195.018.07 |