stenoses of brain arteries, Moyamoya, AVM
Conditions
Interventions
Group 1: Patient group:
Adult patients (=18 years) with neurovascular disease, defined as
=50% stenosis of the internal carotid artery or middle cerebral artery,
Moyamoya disease or comparable angiopa
Sponsors
Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients: - Age =18 years - Written informed consent - Presence of one of the following neurovascular diseases: =50% stenosis of the internal carotid artery or middle cerebral artery, Moyamoya disease or comparable angiopathy, arteriovenous malformation (AVM) Healthy volunteers: - Age =18 years - Written informed consent - No known neurovascular disease
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to both patients and healthy volunteers: - Inability to provide informed consent - Refusal or withdrawal of informed consent - Severe pulmonary disease - Brain tumors, chronic inflammatory brain diseases, or other neurological disorders that may substantially interfere with assessment of cerebrovascular reserve - Contraindications to MRI, including: Cardiac pacemakers or other non-MRI-compatible implants Ferromagnetic foreign bodies Pregnancy, breastfeeding, or pregnancy that cannot be excluded Severe claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is CVR of the brain parenchyma measured by bh-fMRI as the absolute and relative change in the BOLD signal following a standardized breath-hold paradigm. The primary analysis compares bh-fMRI-derived CVR between patients with neurovascular disease and age- and sex-matched healthy controls at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - longitudinal changes in bh-fMRI-derived CVR during disease progression and before and after treatment, - intraindividual comparison of CVR between affected and unaffected brain regions, - comparison of bh-fMRI-derived CVR with TCD-derived CVR, - sonographic parameters (including peak systolic velocity and breath-holding index), disease-specific imaging parameters (stenosis grade, infarct volume, AVM volume, blood flow velocity), - perfusion parameters (CBF, CBV, MTT, TTP), - clinical outcome measures (e.g. NIH Stroke Scale, modified Rankin Scale), - neuropsychological measures assessing executive function, attention and processing speed, - correlation of CVR with imaging, clinical and neuropsychological variables, - evaluation of associations between CVR impairment and clinical symptoms as well as the potential role of CVR in supporting therapeutic decision-making. | — |
Countries
Germany
Contacts
Public ContactKatharina Schregel
Universitätsklinikum Jena
Outcome results
None listed