Cerebral small vessel disease
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All subjects: - Age >18 years old - The condition of the patient must be well enough to allow participation in the study, which is decided in consultation with the treating physician.;cSVD patients: - patients who present with a transient ischemic attack (TIA) and cSVD related abnormalities on brain MRI. TIA patients are defined as patients with stroke like symptoms that last no longer than 24 hours. MRI abnormalities include extended white matter lesions, (asymptomatic) lacunar infarcts, microbleeds and enlarged Virchow-Robin spaces. The patients are eligible when the first DCE-MRI scan can be performed 8-12 weeks after the TIA to avoid the acute phase, and the second MRI-scan within four weeks after the first.;Cortical stroke or primary intracerebral hemorrhage patients: - patients who have a clear clinical presentation of either cortical stroke or primary intracerebral hemorrhage confirmed on brain CT. The patients are eligible when the DCE-MRI scans can be performed within 0-6 weeks of the vascular event and on two subsequent days as the vascular permeability may change significantly on the timescale of weeks.
Exclusion criteria
Exclusion criteria: All subjects: - History of cerebrovascular disease (e.g. ischemic/hemorrhagic stroke) - History of other diseases of the central nervous system (e.g. epilepsy, brain tumor, multiple sclerosis) - Contra-indications for MRI examination: e.g. pacemaker; neurostimulator; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; pregnancy and claustrophobia; brain vessel clamps; denture, which contains magnets. - Contra-indication for MRI contrast agent: e.g. strong suspicion for impaired kidney function, previous allergic reaction to contrast agent, dialysis patients - Psychiatric co-morbidity and inability to perform the (DCE-)MRI scans.;cSVD patients - Patients with a potential cardioembolic source (e.g. atrial fibrillation) - Stenosis of *50% of one or both internal carotid arteries ;Cortical stroke or primary intracerebral hemorrhage patients: - Extensive cSVD related abnormalities on brain MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are: Quantitative pharmacokinetic parameter values: Ki, linked to the BBB permeability, and vb linked to the blood volume. Primary endpoint is to assess the reproducibiliy of the quantified pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are: Quantitative parameters: mean Ki and standard error in the mean Ki determined as a function of scan duration. Mean Ki is taken over all ROI*s or all subjects. The standard error is taken as a measure for the reliability. Secondary endpoint is to assess the optimal scan duration without compromizing the reliability of the quantification of the pharmacokinetic parameters. | — |
Countries
Netherlands
Outcome results
None listed