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 range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).
. History of traumatic brain injury
. 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.