Status:
UNKNOWN
The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
307 Hospital of PLA
Conditions:
Moyamoya Disease
TIA
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial st...
Detailed Description
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical ...
Eligibility Criteria
Inclusion
- 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 Health and Welfare of Japan in 2012
- The CVR of patients detected by SPECT is not impaired severely
- The patients didn't suffer stroke before.
- Informed consent obtained from patient or acceptable patient's surrogate
Exclusion
- 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 ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
- 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.
Key Trial Info
Start Date :
December 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03821181
Start Date
December 8 2019
End Date
August 1 2020
Last Update
November 20 2019
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053