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INflammation and cerebral small vessel disease (INSVD) study

INflammation and cerebral small vessel disease (INSVD) study - INSVD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51836
Enrollment
100
Registered
2022-05-24
Start date
2022-12-28
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune system inflammation

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Cognition and clinical (stroke, other cardiovascular disease) 2. BBB leakage on MRI 3.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)