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Clinical Trials/NL-OMON38519
NL-OMON38519
Completed
Not Applicable

Blood-Brain Barrier permeability quantification in cerebral small vessel disease -- reproducibility of dynamic contrast-enhanced MRI - Blood-brain barrier quantification in cerebral small vessel disease

Medisch Universitair Ziekenhuis Maastricht0 sites20 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral small vessel disease
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
20
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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