The main objective is to investigate whether local mast cell activation correlates with an unstable phenotype of the atherosclerotic plaque.Secondary objectives are: 1. To investigate whether elevated systemic mast cell markers are correlated to…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percentage of mast cell activation in stable
versus unstable atherosclerotic plaques.
Secondary outcome
1. To investigate whether elevated systemic mast cell markers are correlated to
the stability of the atherosclerotic plaque. 2. To investigate correlation of
allergies or lung disease with local and systemic mast cell activation in
atherosclerosis 3. To investigate the inflammatory status of other immune cells
(dendritic cells, macrophages, etc) in atherosclerosis. 4. To investigate
whether gender has an effect on immune cell subsets and plaque stability.
Background summary
Unstable atherosclerotic plaques may rupture, which can lead to thrombosis
with subsequent ischemic events such as a cerebral infarction. Preclinical
research has pointed out that the mast cell, a potent immune cell, plays a
major role in the destabilization of atherosclerotic plaques. Up to now, the
cellular composition of human atherosclerotic plaques has been investigated
with immunohistochemistry and rt-PCR. Recently we have developed a novel method
to determine immune cell subsets in atherosclerotic plaques by means of flow
cytometry. This technique does not only allow us to analyse the cellular
contents of the human atherosclerotic plaque, but also to investigate the gene
expression of each unique cell type in the plaque, rather than looking at the
gene expression of all the cells together. This will give us unique new
insights into the composition of immune cells, specifically the mast cell, in
the atherosclerotic plaque.
Additional emphasis will be placed on the difference of the atherosclerotic
plaque composition in men versus women. This is of high social relevance and a
particular area of interest for both the *Nederlandse Hartstichting* (https://
www.hartstichting.nl/vrouwen) and the NWO (program Gender and Health:
http://www.zonmw.nl/nl/programmas/programma-detail/gender-en-gezondheid/algemeen
/)
Study objective
The main objective is to investigate whether local mast cell activation
correlates with an unstable phenotype of the atherosclerotic plaque.
Secondary objectives are: 1. To investigate whether elevated systemic mast cell
markers are correlated to mast cell content in the atherosclerotic plaque. 2.
To investigate whether allergies or lung diseases associate with local and
systemic mast cell parameters in atherosclerosis 3. To investigate the
inflammatory status of other immune cells (dendritic cells, macrophages, etc)
in atherosclerosis 4. To investigate whether gender has an effect on immune
cell subsets and plaque stability.
Study design
Observational study.
Study burden and risks
There will be no additional risk involved for patients, since this study makes
use of waste material harvested during the operation. The extra required blood
sample will be taken during surgery via vena-punction
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing endarterectomy surgery and who are older than 18 years; able to give their consent to enter the study and have signed an informed consent and the agreement form.
Exclusion criteria
Patients younger dan 18 years old.
Patients who are not able to give their consent to enter the study
Patients who have not signed an informed consent and agreement form
Design
Recruitment
metc-ldd@lumc.nl
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 | NL57482.098.17 |