Our objective is to measure systemic glycocalyx volume in patients with premature atherosclerotic disease before the age of 40 years and to compare this with a age and sex matched healthy control group.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac and vascular disorders congenital
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in the volume of the intravascular glycocalyx between the different
subjectgroups.
Secondary outcome
Not applicable.
Background summary
The pathophysiology of premature atherosclerosis is poorly understood. Patients
often display few risk factors, but the clinical manifestations are evident. If
atherosclerosis is expressed at a very young age, it is likely that besides the
classical risk factors there are also genetic factors that play an important
role. Furthermore, there is a big impact on the yet unaffected family members
which would like to know their liability to develop atherosclerosis. The
detection of early vascular alterations could provide this answer. One of these
early vascular alterations might be the changes of the vascular glycocalyx. If
indeed this methodes functions within this hospital and appears to be
succesfull, this might render us the oppertunity to study nonaffected family
members aswell. We therefore hypothezise that subjects with premature
atherosclerosis have a diminished glycocalyx volume as compared to healthy
control subjects. For this purpose we will investigate the glycocalyx volume in
subjects with premature atherosclerosis and healthy control subjects.
Study objective
Our objective is to measure systemic glycocalyx volume in patients with
premature atherosclerotic disease before the age of 40 years and to compare
this with a age and sex matched healthy control group.
Study design
The study will be an observational case control study.
Intervention
Not applicable.
Study burden and risks
The research consists of a single 2.5 hours lasting visit to the azM. Subjects
have to be fasted, meaning that they can't eat, drink or smoke in the 12 hours
before the research. Drinking of water is also prohibited. Preceding to the
research, a short interview is taken concerning medication use and clinical
history. Furthermore, a short physical examination will be done, in which
length, weight and bloodpressure will be determined.
Next, a venflon catheter will be inserted in both arms. A total of 17 blood
samples will be taken (3 x 1 ml, 12 x 7 ml, 1 x 15 ml and 1 x 40 ml). Also,
Dextran 1 (10 ml), fluorescently labelled erythrocytes and dextran 40 (140ml)
will be infused. As mentioned earlier, there is a small chance to a serious
allergic reaction to Dextran 40 (1:2.000) This can be diminished after a bolus
infusion of Dextran 1 to 1:70.000. Futhermore subject's skin and urine might
take on a yellow-orange discolouration as a reaction to sodiumfluorescein, for
maximum 24 hours. Furthermore because of this subjects are advised to stay out
of the sun for 24 hours.
P. Debyelaan 25
6202 AZ Maastricht
Nederland
P. Debyelaan 25
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Cases:
- a cardiac, cerebral or peripheral vascular disease before the age of 40
- a positive family history for cardiovascular disease, defined as a first degree family member with a cardiovascular event before the age of 55 for men and 60 for women. Furthermore, they should be between the age of 35 and 55 years old.
Controls:
-Controls will be defined as healthy in case they have no cardiovascular history, such as no cardiac, cerebrovascular or peripheral artery disease and no complaints of angina, claudication or TIA and no family history for cardiovascular disease. Furthermore, they should be between the age of 35 and 55 years old.
Exclusion criteria
Cases:
- a positive history for hypertension or diabetes mellitus
- pregnancy or lactating women
- subjects below the age of 18
- unable to give informed consent
Controls:
Diseases mentioned at the inclusioncriteria.
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 | NL17929.068.07 |