Clinical trial NCT03627975: Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease
Official title: Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moyamoya Disease
Keywords: revascularization
hemorrhagic moyamoya disease
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Objective: The aim of this study is to perform a prospective, randomized study on hemorrhagic moyamoya disease to confirm the effect of revascularization in China, and to establish specifications and standards to guide the treatment options for hemorrhagic moyamoya disease as well.

Design: This study is a single-center study and plan to include 108 patients. According to a random number table, hemorrhagic moyamoya patients will be assigned to three groups: conservative treatment group, direct revascularization group and indirect revascularization group. A prospective, randomized study will be carried out to evaluate the effect of revascularization and conservative treatment on the reduction of rebleeding risk and improvement of ischemia in adult patients with hemorrhagic moyamoya disease.

Observation Measures: 1.Rebleeding; 2.Cerebral infarction resulting in severe disability (mRS score≥3); 3.Severe disability or death caused by other reasons; 4. Patients in conservative treatment group need revascularization due to progressive ischemic stroke or progressive Transient ischemic attack(TIA).

Eligibility criteria: 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.

Primary outcomes:
measure: Rebleeding
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Severe Disability
timeFrame: Through study completion, an average of 1 year
measure: Severe Disability or Death
timeFrame: Through study completion, an average of 1 year
measure: Vascular Reconstruction due to Progressive Ischemic Stroke or Progressive TIA
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 307th Hospital of Military Chinese People's Liberation Army
state: Beijing
Study officials:
affiliation: The 307th Hospital of Military Chinese People's Liberation Army
name: Lian Lian, Chief
role: STUDY_CHAIR
References: