Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease

Moyamoya Disease Clinical Trial

— ESRHMMD  

Official title:

Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03627975
• Other study ID #: Z171100001017144
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: January 2019
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Lian Duan, Chief
• Phone: 0086-10-66947156
• Email: keyan307[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Moyamoya Disease

Intervention

Procedure:
• Conservative treatment
The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, prevention and treatment of secondary epilepsy, the control of intracranial hypertension, and the corresponding symptomatic and neurotrophic treatment. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) will be performed according to the procedures described by Matsushima. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) by pass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And the STA may not be preserved.

Locations

Country	Name	City	State
China	The 307th Hospital of Military Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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