To investigate the role of the immune and coagulation system on the progression of cerebral SVD
ID
Source
Brief title
Condition
- Allergic conditions
- Central nervous system vascular disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
White matter ultrastructure as assessed with MRI (being the most sensitive
measure of cerebral small vessel disease) and relate this with markers of the
immune and coagulation system.
Secondary outcome
1. Cognition and clinical (stroke, other cardiovascular disease)
2. BBB leakage on MRI
3.
Background summary
Cerebral small vessel disease (SVD) describes a set of pathologies affecting
the smallest blood vessels in the brain. SVD
contributes to up to a fifth of ischemic and hemorrhagic strokes en is the main
vascular cause of dementia. On MRI, SVD is marked
by different types of lesions, including white matter abnormalities, and small
infarcts and hemorrhages. Recent studies indicate that
SVD develops slowly over the years, starting presumably decades before the
typical MRI lesions become apparent. There is increasing evidence that changes
in the immune and coagulation system play a key role in the progression of
cerebral SVD, however, it remains unclear exactly how these changes lead to
microvascular pathology and the MRI markers of SVD.
In order to increase our insight in the etiology and progression of SVD we want
to determine blood and MRI markers of the immune and coagulation system in
patients with cerebral SVD and follow them over the course of 2 years.
Study objective
To investigate the role of the immune and coagulation system on the progression
of cerebral SVD
Study design
longitudinal prospective cohort study
Study burden and risks
Patients will be asked to undergo a standardised MRI, blood withdrawal and
structured questionaires on medical history and cognition and motor
performance. MRI is considered to be safe and without risks, as long all safety
measures are adequately followed. To study the integrity of the
blood-brain barrier during part of the 3 T MRI scan, patients will receive a
gadolinium-based contrast agent. Side effects of injection
of this contrast agent occur very incidentally and include mild effects such as
nausea, headache and injection site reactions (sense
of warm feeling). In case of adverse effects, patients will be treated
reasonably and professionally.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Patient population
1. Have given written informed consent to participate
2. Be aged 40 years and over
3. Have symptomatic cerebral small vessel disease defined as:
• Clinically symptomatic lacunar infarct in presence of white matter
hyperintensities (Fazekas >=1) on MRI
• and/or symptoms of cognitive impairment due to small vessel disease (Fazekas
>= 1) with lacunar infarct on MRI
• and/or gait apraxia/motor impairment presumed due to small vessel disease
(Fazekas >= 1) with lacunar infarct on MRI
If there is a recent history of stroke, baseline MRI will be scheduled at least
3 months after last stroke to exclude BBB changes secondary to acute infarction.
Healthy control population
1. Have given written informed consent to participate
2. Be aged 40 years and over
Exclusion criteria
Patient population
- unable/unwilling to consent including lack of capacity to consent
- vaccination or infection with fever in preceding month
- any stroke cause other than SVD including:
o Cardioembolic source
o Carotid or vertebral stenosis >50% measured on NASCET criteria
- Myocardial infarction in past year
- Vasculitis
- any chronic disease that could lead to brain lesions mimicking SVD (for
example multiple sclerosis)
- contraindications for 3 T MRI
- auto-immune/auto-inflammatory disease
- use of immunomodulating drugs
- Estimated glomerular filtration rate (eGFR) <= 29 ml/min/1.73m2. eGFR needs
to have been measured within the past 3 months in case the last measurement
was <45ml/min/1.73m2, or within the past 13 months in all other cases.
- Another diagnosed chronic neurological condition (e.g. Alzheimer's,
Parkinson's disease, motor neurone disease, multiple sclerosis).
- Limited life expectancy due to another illness or chronic condition making
the 2 year follow-up difficult (e.g. widespread malignancy).
Healthy control population
- Unable/unwilling to consent including lack of capacity to consent
- Contraindications for 3 T MRI
- Vaccination or infection with fever in preceding month
- Any stroke or SVD pathology or symptoms (some white matter hyperintensities
are permitted)
- Another diagnosed chronic neurological condition (e.g. Alzheimer's,
Parkinson's disease, motor neurone disease, multiple sclerosis)
- Myocardial infarction in past year
- Auto-immune/auto-inflammatory disease
- Use of immunomodulating drugs
- Estimated glomerular filtration rate (eGFR) <= 29 ml/min/1.73m2. eGFR needs
to have been measured within the past 3 months in case the last measurement
was <45ml/min/1.73m2, or within the past 13 months in all other cases.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT05746221 |
| CCMO | NL80258.091.22 |