INflammation and cerebral small vessel disease (INSVD) study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>White matter ultrastructure as assessed with MRI (being the most sensitive<br /><br>measure of cerebral small vessel disease) and relate this with markers of the<br /><br>immune and coagulation system. </p><br>

Secondary Outcome Measures