MiCRovascular rarefaction in vascUlar Cognitive Impairment and heArt failure - VCI
- Conditions
- cerebral small vessel disease, vascular cognitive impairment
- Registration Number
- NL-OMON28554
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 115
Inclusion criteria for VCI
VCI due to cSVD defined as:
ovisiting a memory clinic or outpatient clinic Neurology;
ocognitive complaints;
odemonstration of a cognitive deficit: MoCA<26 or impairment in at least 1 cognitive domain in neuropsychological assessment
oimaging 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.
oAge 18 years or older
oAbility to undergo MRI
oCapacity to give written informed consent
oClinical 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 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method