NL-OMON38389CompletedNot Applicable
The RVCL-MRI study: neuroimaging findings and cerebrovascular reactivity in preclinical and clinical disease stages of Retinal Vasculopathy with Cerebral Leukodystrophy (RVCL), in migraine patients and healthy controls. - RVCL-MRI study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Patient group (RVCL and migraine):
- •- age >=18 years
- •- Diagnosed with :
- •i) RVCL with proven TREX1 mutation; AND/OR
- •ii) migraine with or without aura according to the criteria of the International Headache Society (IHS)
- •- ability and willingness to provide written informed consent;control subjects:
- •-age >=18 years
- •- Not genetically related to an RVCL patient OR genetic testing has ruled out TREX1 mutations
- •- no (history) of migraine attacks
- •- age and sex matched with the patients
- •- Ability and willingness to provide written informed consent
Exclusion Criteria
- •All subjects:
- •- Subjects who do not want to be informed about unexpected findings that are considered serious, with prognostic or therapeutic consequences. This does not concern genetic test results.
- •- History of severe kidney dysfunction
- •- Previous allergic-like reaction to gadolinium-containing contrast agents
- •- Contraindications to MR Imaging (such as presence of metal objects in/on the body that cannot be removed);Migraine patients and control subjects:
- •- Presence of known (cerebro) vascular diseases such as overt manifestations of hypertensive/ atherosclerotic vascular disease, excessive anticoagulation (INR >3.0), CNS disorders, vasculitis, blood dyscrasia, diabetes mellitus, severe clinical relevant carotid artery stenosis. ;Specific exclusion criteria for participants in the cerebrovascular reactivity measurements:
- •- Severe asthma
- •- Seizures within the previous year
Investigators
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