Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03627975
Status:
UNKNOWN
Last Update Posted:
2019-01-31
First Post:
2018-07-29
Brief Title:
Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease
Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Organization:
Affiliated Hospital to Academy of Military Medical Sciences
Study Overview
Official Title:
Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESRHMMD
Brief Summary:
Moyamoya DiseaseMMD 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 anteriormiddle 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 intracranialextracranial 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 1Rebleeding 2Cerebral infarction resulting in severe disability mRS score3 3Severe disability or death caused by other reasons 4 Patients in conservative treatment group need revascularization due to progressive ischemic stroke or progressive Transient ischemic attackTIA
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 1Rebleeding 2Cerebral infarction resulting in severe disability mRS score3 3Severe disability or death caused by other reasons 4 Patients in conservative treatment group need revascularization due to progressive ischemic stroke or progressive Transient ischemic attackTIA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None