1. To either confirm or refute the hypothesis that a subset of brain regulatory T cells exists in humans and expands after stroke.2. To identify immunological biomarkers that can be used in stroke clinical trials targeting the adaptive immune system…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will assess the amount and characteristics of regulatory T cells in
peripheral blood, lymph nodes and different brain areas of stroke patients and
compare these with patients without stroke.
Secondary outcome
To determine the immune temporal cellular landscape of the immune system in
patients with acute stroke in the brain multiple study parameters are assessed
(we will integrate results from brain histopathology, flow cytometric
characterization of T cell subsets, CITE-seq, and spatial single-cell RNA
sequencing (spatial scRNA-seq) analyses).
Background summary
Despite novel acute therapies the global burden of stroke remains high
worldwide. Targeting the immune response after stroke has the potential to
improve recovery in all stroke patients. Experimental studies suggest important
roles for T-lymphocytes, especially anti-inflammatory regulatory T cells, in
the evolution of stroke and neurological deficit.
Study objective
1. To either confirm or refute the hypothesis that a subset of brain regulatory
T cells exists in humans and expands after stroke.
2. To identify immunological biomarkers that can be used in stroke clinical
trials targeting the adaptive immune system.
Study design
case control study.
Study burden and risks
In 60 patients blood will be sampled at 9 time points. In addition, neurologic
examination at 5 time points, 1 MRI scan and 1 telephone interview will be
performed. In 10 patients who undergo carotid endarterectomy, a lymph node will
be extracted and blood will be drawn during this surgery. The study is carried
out in both capacitated and incapacitated persons because exclusion of
non-communicative stroke patients would lead to a selective patient sample.
Meibergdreef 9
Amsterdam 1105 HZ
NL
Meibergdreef 9
Amsterdam 1105 HZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in part 1 of this study (serial
bloodsampling and cervical lymph node sampling), a subject must meet all of the
following criteria:
- age 18 years or older,
- clinical symptoms of hemispheric ischemic stroke due to occlusion of a large
vessel
- an onset of symptoms less than 48 h
- a score of 1 or more on the National Institutes of Health Stroke Scale
(NIHSS)
- admission to hospital
- written informed consent obtained
For the control arm of the study:
- age 50 years or older,
- written informed consent obtained
- increased risk of cardiovascular disease (defined as a previous
cardiovascular event other than stroke or one of the following risk factors:
smoking, hypertension, hypercholesterolaemia, diabetes mellitus)
Exclusion criteria
- women of childbearing age
- patients with HIV, lymphoproliferative or immunological diseases
- infection at admission for which antibiotic therapy is initiated
- patients using immunosuppressive medication
- imminent death
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 | NL75373.018.20 |