Our primary objective is to measurec glycocalyx volume with OPS imaging, before and after sublingual nitroglycerine-spray administration, in patients with premature atherosclerotic disease before the age of 40 years and a positiev family history for…
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
Change in glycocalyx volume, before and after sublingual nitroglycerine
administration between the different study groups
Secondary outcome
To compair the glycocalyx volume of the different study groups we measure this
year, with last year's measurements.
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 genetic factors play an important role. Therefore, it is
of relevance to develop a methode, which can identify subjects at risk at an
early stage. The detection of early vascular alterations is therefore of major
importance, especially in unaffected subjects of families with premature
atherosclerosis. A dimished glycocalyx volume is thought to represent early
vascular injury and therefore seems the ideel target for investigation.
From our previous research, we showed that subjects with premature
atherosclerosis had a smaller glycocalyx volume as compared to healthy
subjects. Unfortunately, we used an invasieve technic to establish glycocalyx
volume. If we can develop a new non-invasive method (OPS imaging) to measure
glycocalyx volume, this would lead to the development of a better tool, to
detect early vascular alterations. This could lead to a method that is
applicable in large scale patient populations.
For this purpose we will investigate the glycocalyx volume in subjects with
premature atherosclerosis and healthy control subjects.
Study objective
Our primary objective is to measurec glycocalyx volume with OPS imaging, before
and after sublingual nitroglycerine-spray administration, in patients with
premature atherosclerotic disease before the age of 40 years and a positiev
family history for cardiovascular disease and to compare this with a age and
sex matched healthy control group.
Study design
The study will be an observational case control study.
Study burden and risks
The research consists of a single 30 minutes lasting visit to the azM. Subjects
will come fasted, meaning that they can't eat, drink or smoke in the 12 hours
before the research. Drinking of water is permitted. The ivestigation will
start with a short questionairre concerning medication use and clinical
history. After that, two non-invasive sublingual OPS glycocalyx imaging
measurements will be made, before and after sublingual nitroglycerine-spray
administration. De risks of applying his drug is minimal, patients could suffer
from a headache, which can be antagonated by a cop of coffee.
Universiteitssingel 50
6200 MD Maastricht
Nederland
Universiteitssingel 50
6200 MD 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 36 and 56 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 36 and 56 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
Medical products/devices used
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 | NL26075.068.08 |
| Other | Nog niet bekend. |