Biomarker-Led Optimization of Successful Surgical Outcomes in Moyamoya (NCT06634004) | Clinical Trial Compass
By InvitationNot Applicable
Biomarker-Led Optimization of Successful Surgical Outcomes in Moyamoya
United States100 participantsStarted 2023-09-11
Plain-language summary
The goal of this work is to use advanced magnetic resonance imaging (MRI) methods to assess brain blood flow and vascular function in adults with moyamoya disease (MMD). MMD is a condition characterized by narrowing or obstruction of major arteries in the brain and people with MMD have a high risk of stroke. Study participants will be enrolled from Vanderbilt University Medical Center and Johns Hopkins Hospital and will undergo up to two MRI scans where measurements of cerebrovascular reserve are performed using inhaled room air mixed with 5% carbon dioxide. Scans will be performed before and after surgeries to treat MMD, all surgeries are clinically indicated and are not research procedures. To further understand how surgeries impact brain health, we will also perform neurological exams and cognitive testing at approximately the same time as the imaging scans. The overall goal is to incorporate advanced imaging and cognitive assessments to understand how surgeries improve brain health in these patients, and furthermore, to use this information to develop improved screening tools for stroke risk and decisions about surgery.
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion criteria
✓. Clinical diagnosis of moyamoya disease as defined by gold-standard catheter angiography and consensus adjudication of imaging and neurological findings
✓. Age = 18-60 years
✓. Participants for the surgical revascularization aims must be scheduled for clinically indicated indirect surgical revascularization of at least one hemisphere
✓. Speak and read English
✓. No major medical conditions
✓. Age = 18-60 years
✓. Speak and read English
✓. Able to complete 2 study MRIs and all other study procedures
Exclusion criteria
✕Both moyamoya and healthy controls
✕. History of other major neurological conditions (including but not limited to Parkinson\'s disease, Alzheimer\'s disease, and Multiple Sclerosis) as confirmed by neuroimaging and neurological evaluation (central adjudication committee).
✕. Independent medical condition expected to lead to death within two years.
✕. Condition associated with syndromic moyamoya (including but not limited to sickle cell disease, atherosclerosis, neurofibromatosis, Down syndrome).
✕. Severe respiratory illness including but not limited to asthma or chronic obstructive pulmonary disease.