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Tests treatment safety and results for Moyamoya Disease
Official title Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
ClinicalTrials.gov ID: NCT03546309
What this study is testing
- What it's testing
- Revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric Moyamoya disease (MMD) patients with ischemic symptoms. However, perioperative complications, such as hyperperfusion syndrome, new infarct on imaging, or ischemic stroke, are inevitable.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Age: ≥0 and ≤18
- All of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD...
- Suzuki stages concentrated in Stage III and IV
- Presentation with ischemic symptoms, such as transient ischemic attack (TIA), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by...
- Informed consent obtained from patient or acceptable patient's surrogate
You likely can't join if
- Severe hepatic or renal dysfunction
- Severe hemostatic disorder or severe coagulation dysfunction
- Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis...
- Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick...
- Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
- Patient participating in a study involving other drug or device trial study
See the full eligibility criteria
- Age: ≥0 and ≤18
- All of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of...
- Suzuki stages concentrated in Stage III and IV
- Presentation with ischemic symptoms, such as transient ischemic attack (TIA), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by MRI
- Informed consent obtained from patient or acceptable patient's surrogate
- Severe hepatic or renal dysfunction
- Severe hemostatic disorder or severe coagulation dysfunction
- Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy
- Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left...
- Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
- Patient participating in a study involving other drug or device trial study
- Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Unlikely to be available for follow-up for 3 months
- Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.