The principal aim of this study is to examine whether glycocalyx volume, as estimated by SDF-imaging, is associated with cardiovascular risk as estimated by conventional risk scores.
ID
Source
Brief title
Condition
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Association between estimated glycocalyx volume and cardiovascular risk as
estimated by conventional risk scores.
Secondary outcome
- Variation of estimated glycocalyx volume in the entire study population.
- Variation of estimated glycocalyx volume in subgroups of patients divided by
predicted cardiovascular risk.
Background summary
Further improvement in cardiovascular disease management in individuals calls
for novel strategies to detect early atherosclerotic changes, before overt
cardiovascular disease exists.
The endothelial glycocalyx ,recently emerged as an important regulator of
vascular homeostasis and perturbation of this structure, has been associated
with cardiovascular disease. The endothelial glycocalyx may therefore be a
potential target for treatment as well as for the identification of individuals
at increased risk for cardiovascular disease. Thus far however, non-invasive
measurement of glycocalyx volume was not possible. Therefore, glycocalyx
properties have only been investigated in small selected patient groups.
Estimation of endothelial glycocalyx volume by Sideview Dark-Field (SDF)
imaging of the sublingual microcirculation may be a promising technique.
Large-population data are however not yet available. In this study, we aim to
asses the association of glycocalyx volume as estimated by SDF-imaging with
conventional cardiovascular risk scores. We hypothesize that the estimated
glycocalyx volume is diminished in subjects with higher cardiovascular risk
scores.
Study objective
The principal aim of this study is to examine whether glycocalyx volume, as
estimated by SDF-imaging, is associated with cardiovascular risk as estimated
by conventional risk scores.
Study design
This is a cohort study. Patients will attend one visit in which they will be
subjected to a questionnaire and sublingual visualization of the
microcirculation using the SDF-camera. The questionnaire will be used to assess
the cardiovascular risk profile of individuals. In addition to general
information such as date of birth, gender and ethnicity, information will be
gathered on the medical history, medication use, intoxication and family
history. The questionnaire will be completed in approximately 15 minutes.
Laboratory data and data on the physical examination performed by the treating
physician will be adopted from the patients charts after the study visit.
Finally, the sublingual microcirculation will be visualized by SDF-imaging. The
SDF-camera may be handled by the patients. This measurement will take 5
minutes.
Study burden and risks
The nature of the burden consists of an SDF measurement , a non-painful,
non-invasive 5 minute procedure using small camera surrounded by a circle of
led lights which can be applied to the sublingual microcirculation. In
addition, a questionnaire will be completed which will take approximately 15
minutes. There are no invasive procedures to this study and therefore there is
no risk associated with participation.
We consider the burden for participants not to be higher than any regular visit
to the outpatient department. They will only be asked to stay an additional 20
minutes in the hospital. There is no benefit for individual participants.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years of age
- Able to provide written informed consent
Exclusion criteria
- Chronic inflammatory disease
- Malignancy
- Pregnancy
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 | NL38826.018.12 |