To investigate the role of the immune system in the etiology and prognosis in an acute ischemic stroke (or TIA) in young stroke patients.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the role of the immune system in the cause of a first-ever ischemic
stroke or TIA before their 50th year?
Secondary outcome
• What is the role of triggerfactors on the immune system in patients with a
first-ever ischemic stroke or TIA before their 50th year?
• What is the role of the immune system on the vascular wall function in
patients with a first-ever ischemic stroke or TIA before their 50th year?
• What is the risk of long term complications in patients who suffer from an
ischemic stroke or TIA between their 18th and 50th year?
• What is the impact of a first-ever ischemic stroke or TIA before their 50th
year on the functional prognosis?
• What is the effect of coping strategies on cognitive and functional prognosis
in patients with a first-ever ischemic stroke or TIA before their 50th year?
Background summary
Yearly, approximately 1200 young adults have a stroke in the Netherlands. In
contrast to the older stroke population, a lot remains unknown regarding the
etiology, secondary prevention and especially the long-term prognosis for these
"young stroke" patients. In the elderly, cardiac problems and atherosclerosis
are the main causes of stroke. However, these causes are much less frequent in
the young. In around 20% of young patients the stroke is caused by a
heterogeneous group of rare diseases and in even 30-40% the cause of stroke
remains completely unknown.
These different etiologies or even unknown etiology combined with a longer
life-expectancy in these young adults compared to the older patients, means
that study results on prognosis and secondary prevention cannot just be
extrapolated from trials and studies in the elderly stroke population.
Based on our own young stroke studies, we observed that so called
triggerfactors such as a fever or inflammation days before a stroke might play
a role in etiology. This suggest that an interaction between inflammation and
coagulation (the immune system) might lead to a stroke in vulnerable
individuals. That is why we want to investigate the role of the immune system
in the development of a stroke at young age. Additionally, studies suggest that
patients with a disruptive immune system after a stroke have worse functional
prognosis. However, studies about the long term effects of a disruptive immune
system in young stroke patients are not known.
Study objective
To investigate the role of the immune system in the etiology and prognosis in
an acute ischemic stroke (or TIA) in young stroke patients.
Study design
Multi-center prospective cohort study
Study burden and risks
Blood will be collected from patients twice and patient will undergo an 3T MRI
once. Additionally, we have questionnaires (online/via telephone) which contain
questions about triggerfactors, incidence cardiovascular events, post-stroke
epiplepsy, medication use, daily and social functioning, coping and subjective
cognition.
There are no big risks regarding the 3T MRI in patients without
contraindication and can be safely performed. Some patients experience some
discomfort due to the MRI. Patients will be provided with air protection for
the sound and protection of the ear. Additionally, we try to reduce discomfort
for the patients by providing pillows when laying down. Patients can always
stop the MRI scan at every random moment. There is a small risk of bruising,
bleeding or infection by positioning an infusion line or an allergic reaction
to the Gadovist contrast.
Reinier postlaan 4
Nijmegen 6500 HB
NL
Reinier postlaan 4
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Patients with a first-ever transient ischemic attack (TIA) or acute ischemic
stroke aged between 18 and 50 years old will be included. For this study, acute
stroke is defined as "occurence of acute neurological deficit lasting more than
24 hours, with confirmation on imaging (CT(-a) or MR(-a))".TIA is defined as
"occurence of acute neurological deficit lasting less than 24 hours with
confirmation of ischemia on MRI). Patients are able to provide informed consent
and a kidney function eGFR>30ml/min.
Exclusion criteria
Main exclusion criteria are: history of clinical TIA, ischemic stroke or
intracerebral hemorrhage. A intracerebral hemorrhage resulting from trauma,
known aneurysm or underlying intracerebral malignancy. A venous infarction,
retinal infarction and amourosis fugax. Inadequate control of the Dutch
language to reliably sign an informed consent from and/or participate in the
follow-up. Patients are excluded if they have a contra indication for 3T MRI.
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 | NL77518.091.21 |