Skip to content

MiCRovascular rarefaction in vascUlar Cognitive Impairment and heArt failure - VCI

MiCRovascular rarefaction in vascUlar Cognitive Impairment and heArt failure - VCI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28554
Enrollment
115
Registered
2020-02-13
Start date
2020-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

cerebral small vessel disease, vascular cognitive impairment

Interventions

observational study
none

Sponsors

Maastricht University Medical Center
Lead Sponsor

Eligibility

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<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 (Fazekas 1) 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 =1 Inclusion criteria for controls • visiting the outpatient clinic Neurology with complaints related to the peripheral nervous system (e.g. chronic polyneuropathy, carpal tunnel syndrome or neurogenic claudicatio intermittens). • No cognitive complaints • No objective cognitive deficit • 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 • 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 <30 ml/min) • Other major neurological or psychiatric conditions affecting the brain and interfering with the study design, among which: multiple sclerosis, Parkinson’s disease, alcohol/drug abuse, major cortical stroke, major neuro-trauma, brain tumors. Exclusion criteria for cardiac MRI (VCI only) • Asthma and/or COPD • Slow heart rhythm (<50 beats per minute) • Irregular heart rhythm (i.e. atrial fibrillation) • AV-block II-III • Sick sinus syndrome • Prolonged QT-interval • Hypotension defined as systolic blood pressure less than 90 mmHg • Decompensatio cordis

Design outcomes

Primary

MeasureTime 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) •Cognitive function: overall and domains of memory, information processing speed, executive function

Secondary

MeasureTime frame
VCI patients only • Cardiac: - 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 - 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 • 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 • Sublingual flow-related capillary density (GlycoCheck)

Contacts

Public ContactRobert Jan van Oostenbrugge

Maastricht UMC+

r.vanoostenbrugge@mumc.nl0433877058

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)