The primary objective of this study is to measure the number of antigen specific T-cells in the plaque and in blood, and investigate whether these parameters correlate with the phenotype of the atherosclerotic plaque. Secondary objectives are: 1) To…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to measure the number of antigen
specific T-cells in the plaque and in blood, and investigate whether these
parameters correlate with the phenotype of the atherosclerotic plaque.
Secondary outcome
Secondary objectives are: 1) To investigate the inflammatory status of other
immune cells (dendritic cells, macrophages, mast cells, etc) in atherosclerosis
by flow cytometry and gene expression analysis. 2) To correlate plaque
phenotype to CT-angiography plaque characteristics. 3) To investigate whether
gender has an effect on these T-cells and other immune cell subsets and plaque
phenotype.
Background summary
Atherosclerosis is the primary cause of major adverse cardiovascular events
(MACE), including myocardial infarction (MI) and stroke. It is characterized by
lipid accumulation and inflammation in middle and large-sized arteries. T-cells
play an important role in the propagation of inflammation inside the lesion.
Moreover, these cells have been shown to actively contribute to plaque
destabilization. Elevated numbers of T-cells in blood have been shown to
correlate with MACE. Although these are encouraging results, these analyses are
compromised by the presence of T-cells that are not derived from the
atherosclerotic lesions and are not involved in mediating inflammation in the
atherosclerotic lesion, thereby decreasing their prognostic value. We
hypothesize that determining the number of T-cells that are specifically
associated with atherosclerosis will provide a more accurate and robust
prediction of plaque phenotype and potential instability. Previous studies
investigating mouse and human atherosclerosis suggest T-cells may react towards
the proteinous components of LDL (the ApoB100 protein). T-cells reactive to the
antigen ApoB100 may play an important role in progression of atherosclerosis
and the number and/or activation state of these T-cells in blood may reflect
the stage of atherosclerosis.
Study objective
The primary objective of this study is to measure the number of antigen
specific T-cells in the plaque and in blood, and investigate whether these
parameters correlate with the phenotype of the atherosclerotic plaque.
Secondary objectives are: 1) To investigate the inflammatory status of other
immune cells (dendritic cells, macrophages, mast cells etc) in atherosclerosis.
2) To correlate plaque phenotype to CT-angiography plaque characteristics. 3)
To investigate whether gender has an effect on these T-cells, other immune cell
subsets and plaque phenotype.
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 prior to surgery via vena punction (and prior to general
anaesthesia).
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients undergoing endarterectomy surgery
- Patients who are older than 18 years
- Patients able to give their consent to enter the study
- Patients who have signed an informed consent and the agreement form.
Exclusion criteria
- Patients younger than 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 the agreement form.
- Patients that have already had an endarterectomy previously and are
undergoing a redo of this surgery.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NL71516.058.19 |