Blood-brain barrier in cerebral small vessel disease.

Blood-brain barrier in cerebral small vessel disease, a dynamic contrast-enhanced MRI study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26559

Enrollment

120

Registered

2013-01-09

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Blood-brain barrier, cerebral small vessel disease, lacunar stroke, cognitive impairment, DCE-MRI

Interventions

Participants will receive: At baseline: 1. A structural brain MRI scan

2. A DCE-MRI scan

3. A neuropsychological assessment

4. Blood sampling

5. Sublingual glycocalyx measurement. At follow-up: 1. A 2nd structural brain MRI

2. A 2nd neuropsychological assessment.

Eligibility

Inclusion criteria

Inclusion criteria: Patients with lacunar stroke, patients with mild vascular cognitive impairment (VCI), and healthy subjects will be included. Criteria for all subjects: 1. Age >18 year. Criteria specifically for lacunar stroke patients: 1. A first-ever acute lacunar stroke. Criteria specificaly for mild VCI due to cerebral small vessel disease (cSVD): 1. Subjective complaints of cognitive functioning and objective cognitive impairment in at least 1 cognitive domain on cognitive testing, and; 2. A Clinical Dementia Rating ≤1 and a MMSE ≥20 (i.e. no dementia), and; 3. Vascular lesions on brain MRI (lacunar infarts, white matter lesions, deep microbleeds) that suggest a link between the cognitive deficit and cSVD. Healthy control subjects: 1. Healthy control subjects included from the general and matched to the LACI and mild VCI patients according to gender and age.

Exclusion criteria

Exclusion criteria: Exclusion criteria for all subjects: 1. Age <18 year; 2. Cerebrovascular abnormalities in history: A. Ischemic stroke; B. Haemorrhagic stroke (subarachnoid or intracerebral). 3. Contra indications for MRI/DCE-MRI: A. Heart valve prosthesis; B. Pacemaker; C. Intracerebral clips (aneurysm); D. Intra-ocular metal pieces; E. Cochlear implant; F. Claustrophobia; G. Poor kidney function (GFR<30ml/min); H. Previous allergic reaction to contrast agent (gadobutrol). 4. Psychiatric disorders associated with (temporarily) cognitive decline (e.g. depression, psychosis). Group specific exclusion criteria: Lacunar stroke: 1. Potential cardiac embolic source (e.g. atrial fibrillation); 2. Stenosis of ≥50% of one or both internal carotid arteries. Mild VCI due to cSVD: 1. Clinical and/or subclinical cortical events; 2. Other causes for cognitive impairment (e.g. Alzheimers Disease). Healthy subjects: 1. Clinically overt cardiovascular diseases; 2. Clinically overt cerebrovascular diseases; 3. Disease of the central nervous system (e.g. Multiple Sclerosis, brain tumor/metastasis); 4. Extensive structural lesions on MRI associated with cSVD; 5. Cognitive impairment (i.e. objective and/or subjective cognitive deficits).

Design outcomes

Primary

Measure	Time frame
1. Quantified BBB permeability in cSVD patients and healthy controls; 2. Cognitive function, related to BBB permeability, at baseline and at follow-up.	—

Secondary

Measure	Time frame
Structural brain lesions on MRI, related to BBB permeability, at baseline and at follow-up.	—

Contacts

Public ContactC.E. Zhang

P. Debyelaan 25

eleana.zhang@mumc.nl+31 (0)43 3872907

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)