cerebral small vessel disease vascular cognitive impairment
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for VCI: VCI due to cSVD defined as: o visiting a memory clinic or outpatient clinic Neurology; o cognitive complaints; o demonstration of a cognitive deficit: MoCA less than 26 or impairment in at least 1 cognitive domain in neuropsychological assessment o imaging evidence of cerebral small vessel disease: - extensive leukoaraiosis on CT, or - (early) confluent WMH on MRI (Fazekas score >= 2), or * - multiple punctate WMH on MRI in combination with lacunar infarcts or microbleeds. o Age 18 years or older o Ability to undergo MRI o Capacity to give written informed consent o Clinical dementia rating scale 3 months after stroke onset to avoid acute stroke effects) o Additional imaging evidence of cerebral small vessel disease: * extensive leukoaraiosis on CT, or * (early) confluent WMH on MRI (Fazekas score >= 2), or * Lacunar infarct in combination with multiple punctate WMH on MRI (Fazekas 1) or microbleeds. • Age 18 years or older • Ability to undergo MRI • Capacity to give written informed consent The controls are defined as: - persons visiting the outpatient clinic Neurology - complaints of the peripheral nervous system due to a.o. chronic polyneuropathy, ulnaropathy or carpal tunnel syndrome - no cognitive complaints and/or symptoms - age over 18 years - Ability to undergo MRI - Capacity to give written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for both VCI and controls • Inclusion criteria are not met • Unwillingness or inability to give written consent • mentally incompetent (or reasonable doubt about competence) to give informed consent • Contraindications to MRI, among which: pacemaker, metallic foreign body, claustrophobia, pregnancy, neurostimulator, other kinds of implanted devices or insulin pump • Contraindications to gadolinium contrast agent used for MRI, among which allergy or severe renal impairment (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Advanced brain MRI markers for microvascular hypoperfusion and dysfunction: -BBB leakage rate and fractional volume (DCE-MRI) -grey matter perfusion (ASL-CBF) -microvascular perfusion volume (IVIM) -parenchymal diffusivity/microstructural integrity (IVIM) -macrovascular perfusion (GE-DSC-MRI) -microvascular perfusion (capillary transit time heterogeneity on GE-DCS-MRI or SE-DSC-MRI) • Structural vascular markers: total brain volume, white matter hyperintensities volume, visual assessment of WMH Fazekas score, lacunes, microbleeds, perivascular spaces, total SVD burden score.28, 29 • Cognitive function: overall and domains of memory, information processing speed, executive function | — |
Secondary
| Measure | Time frame |
|---|---|
| VCI patients only • Cardiac: o echocardiography: Left ventricular (LV) end-diastolic and -systolic diameters, LV mass and the LV mass index, and left atrial volume and left atrial volume index, LV ejection fraction, global and regional longitudinal strain o MRI: ejection fraction, diastolic volume, end systolic function, cardiac output, left ventricular mass, diastolic function (early to late ventricular filling ; E/A ratio), left atrial volume as measure for diastolic function. Myocardial perfusion from the adenosine stress test. o Serum markers of cardiac damage/strain (NT-proBNP, hs-TNT), fibrosis (PICP, CITP:MMP-1) and inflammation (Gal-3, sST-2) • Microvesicles: RNA content of endothelial derived microvesicles • Vascular density on OCT angiography of the eyes • Retinal vessel diameters and branching complexity measures (fundus imaging) • Sublingual flow-related capillary density (GlycoCheck) • Platelet hemostatic- and inflammatory function • Tear fluid gadolinium | — |
Countries
Netherlands
Outcome results
None listed