Moyamoya Disease Clinical Trial
— ESRHMMDOfficial title:
Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease
Moyamoya Disease(MMD), also known as spontaneous basilar artery occlusion, is characterized by the gradual thickening of arterial intima at the distal carotid artery and the proximal portion of anterior/middle cerebral artery, the gradual stenosis or occlusion of arterial lumen, and the compensatory expansion of basilar cerebral perforating arteries. Cerebral infarction and cerebral hemorrhage are common clinical symptoms of MMD with high morbidity of disability. For ischemic moyamoya disease, intracranial/extracranial revascularization is the preferred treatment. However, for patients with hemorrhagic moyamoya disease, there is controversy about whether to have surgical treatment, the timing and the method of surgical treatment, and the effect of surgical treatment to prevent rebleeding due to the lack of large sample, multi-center, prospective randomized studies. At present, the studies on the effect of revascularization and conservative treatment on hemorrhagic moyamoya disease are retrospective case analyses without randomized control. The sample size of these studies are small, and the conclusions obtained are inconsistent. Due to the differences in the epidemiology and episode type of moyamoya disease in different countries, there is no prospective, randomized controlled study of blood type moyamoya disease in China to confirm the efficacy of revascularization and lack of uniform norms and standards.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery - Abnormal vascular network appeared in the brain - Lesions showed bilateral changes - Age=18 years - With the onset of cerebral hemorrhage - No cerebral infarction or cerebral hemorrhage occurred within the last month - At least one month after the acute phase of cerebral hemorrhage or related diseases was treated Exclusion Criteria: - Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc.. - Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded. |
Country | Name | City | State |
---|---|---|---|
China | The 307th Hospital of Military Chinese People's Liberation Army | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Affiliated Hospital to Academy of Military Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rebleeding | All enrolled patients were followed up regularly by telephone, outpatient and inpatient visits. The observed end-point events of rebleeding | Through study completion, an average of 1 year | |
Secondary | Severe Disability | Cerebral infarction resulting in severe disability (mRS score=3) | Through study completion, an average of 1 year | |
Secondary | Severe Disability or Death | Severe disability or death caused by other reasons | Through study completion, an average of 1 year | |
Secondary | Vascular Reconstruction due to Progressive Ischemic Stroke or Progressive TIA | Patients in conservative treatment group needs vascular reconstruction due to progressive ischemic stroke or progressive TIA. | Through study completion, an average of 1 year |
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