1.01.02
2021:02:25 22:12:54.934
moyamoya
368817
31
1
3
3
NCT03613701
8157113
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Relationship Between Endothelial Progenitor Cells and Revascularization Effect of Moyamoya Disease
Relationship Between Endothelial Progenitor Cells and Revascularization Effect of Moyamoya Disease
REPCREMMD
January 2019
Unknown status
Recruiting
No
September 1, 2017
Actual
September 1, 2019
Anticipated
December 1, 2020
Anticipated
July 29, 2018
August 2, 2018
August 3, 2018
Actual
January 29, 2019
January 31, 2019
Actual
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
No
No
Moyamoya disease is a chronic cerebrovascular disease,The typical pathological manifestations are the stenosis or occlusion of the distal internal carotid artery and/or middle cerebral artery, and the proximal anterior cerebral artery. Meanwhile, the abnormal vascular net, which is the smokey vessel, occurs at the bottom of the brain. Currently the pathogenesis of this disease is unknown. Limited studies have reported the expression of endothelial progenitor cells (EPCs) in moyamoya disease, but the results were inconsistent. Some investigators believe that the number of EPCs in peripheral blood of patients with moyamoya disease is increased, while others believe that the number of EPCs in peripheral blood of moyamoya patients is reduced. Therefore, the investigators need to find a more accurate detection method to confirm the growth of EPC in patients with moyamoya disease. At the same time, whether there is endothelial injury in patients with smoke disease, and the expression of endothelial cells (CEC) in patients with smoke disease, there is no research on this aspect at home and abroad.
Objective: Detect the expression of endothelial progenitor cells and endothelial cells from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.
Design: A single center study, and planned to enroll 120 patients. The present study was to detect the quantities of EPC from peripheral blood in Moyamoya disease by flow cytometry, and to identify the relationship of endothelial progeIlitor cells and effect of the revascularization on Moyamoya disease. The present study also use cerebral ischemia animal model foe intervention experiment, to explore whether EPC can promote vascular remodeling effect of ischemic cerebrovascular disease, and to provide new thought for the treatment of chronic cerebrovascular disorder.
Moyamoya Disease
Moyamoya disease
Endothelial progenitor cells
revascularization
Observational
Yes
6 Months
Case-Control
Prospective
120
Anticipated
Moyamoya disease patients
Moyamoya disease patients/Healthy volunteers
Expression of endothelial progenitor cells and endothelial cells in peripheral blood
Expression of endothelial progenitor cells and endothelial cells in peripheral
2017.9-2018.8
Inclusion Criteria:
Whole-brain vessels angiography or magnetic resonance arteriography (MRA) has the following manifestations: stenosis or occlusion of terminal internal carotid artery or the anterior cerebral artery and/or initiating middle cerebral artery; In the arterial phase, the abnormal smokey vascular net near the occlusive or stenosis lesion can be seen.
For patients with stable stroke, there was no acute or subacute cerebral infarction or cerebral hemorrhage, and at least 3 months before the last cerebral infarction or cerebral hemorrhage events.
Exclusion Criteria:
Exclude atherosclerosis, autoimmune diseases, meningitis, intracranial tumors, multiple neurofibromatosis, Down syndrome, craniocerebral trauma, radiation injury, and other underlying diseases that may cause smoke.
Acute or subacute cerebral infarction or cerebral hemorrhage were excluded.
Accepts Healthy Volunteers
All
18 Years
60 Years
Adult
Health volunteers' inclusion criteria:
Age between 18-60;
Male or female;
Exclusion criteria:
Exclude the volunteers with history of cerebrovascular disease and heart disease.
Probability Sample
Lian Duan, Chief
Contact
0086-10-66947156
keyan307@163.com
Lian Duan, Chief
The 307th Hospital of Military Chinese People's Liberation Army
Study Chair
The 307th Hospital of Military Chinese People's Liberation Army
Recruiting
Beijing
Beijing
100071
China
Lian Duan, Chief
Contact
0086-10-66947156
keyan307@163.com
No
February 26, 2021
D000009072
Moyamoya Disease
D000002340
Carotid Artery Diseases
D000002561
Cerebrovascular Disorders
D000001927
Brain Diseases
D000002493
Central Nervous System Diseases
D000009422
Nervous System Diseases
D000002539
Cerebral Arterial Diseases
D000020765
Intracranial Arterial Diseases
D000001157
Arterial Occlusive Diseases
D000014652
Vascular Diseases
D000002318
Cardiovascular Diseases
M10615
Moyamoya Disease
Moyamoya Disease
high
M4176
Carotid Artery Diseases
low
M4393
Cerebrovascular Disorders
low
M3786
Brain Diseases
low
M4325
Central Nervous System Diseases
low
M4371
Cerebral Arterial Diseases
low
M21105
Intracranial Arterial Diseases
low
M3046
Arterial Occlusive Diseases
low
M15983
Vascular Diseases
low
T3892
Moyamoya Disease
Moyamoya Disease
high
BC10
Nervous System Diseases
BC14
Heart and Blood Diseases
All
All Conditions
Rare
Rare Diseases
NCT02434302
13NR31
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Characteristics and Outcomes of Childhood Moyamoya in the UK
Characteristics and Outcomes of Childhood Moyamoya in the UK
April 2015
Unknown status
Recruiting
No
August 2014
August 2016
Anticipated
August 2016
Anticipated
April 30, 2015
May 4, 2015
May 5, 2015
Estimate
May 4, 2015
May 5, 2015
Estimate
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
No
This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.
The study ahs 3 components:
Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres
Record review/patient interview to determine clinical features & outcomes
Centralised review of imaging data to ascertain radiological phenotypes
Moyamoya
Observational
No
Cohort
Cross-Sectional
150
Anticipated
Number of children with moyamoya in UK
2 years
clinical features & outcomes of childhood moyamoya
2 years
radioplogical features of childhood Moyamoya
2 years
Inclusion Criteria:
Radiological diagnosis of moyamoya
Exclusion Criteria:
Refuse consent
No
All
18 Years
Child
Adult
Children (0-18y) with moyamoya in the UK over study period (2014-2016 August)
Non-Probability Sample
Vijeya Ganesan, MB ChB MD
Contact
02074059200
v.ganesan@ucl.ac.uk
vijeya ganesan, MB ChB MD
UCL Institute of Child Health
Principal Investigator
Great Ormond Street Hospital for CHidlren NHS Foundation Trust
Recruiting
London
WC1N 3LU
United Kingdom
vijeya ganesan, MB ChB MD
Contact
02074059200
v.ganesan@ucl.ac.uk
February 26, 2021
D000009072
Moyamoya Disease
D000002340
Carotid Artery Diseases
D000002561
Cerebrovascular Disorders
D000001927
Brain Diseases
D000002493
Central Nervous System Diseases
D000009422
Nervous System Diseases
D000002539
Cerebral Arterial Diseases
D000020765
Intracranial Arterial Diseases
D000001157
Arterial Occlusive Diseases
D000014652
Vascular Diseases
D000002318
Cardiovascular Diseases
M10615
Moyamoya Disease
Moyamoya
high
M4176
Carotid Artery Diseases
low
M4393
Cerebrovascular Disorders
low
M3786
Brain Diseases
low
M4325
Central Nervous System Diseases
low
M4371
Cerebral Arterial Diseases
low
M21105
Intracranial Arterial Diseases
low
M3046
Arterial Occlusive Diseases
low
M15983
Vascular Diseases
low
T3892
Moyamoya Disease
Moyamoya
high
BC10
Nervous System Diseases
BC14
Heart and Blood Diseases
All
All Conditions
Rare
Rare Diseases
NCT03627975
Z171100001017144
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease
Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease
ESRHMMD
January 2019
Recruiting
No
October 1, 2017
Actual
October 1, 2020
Anticipated
October 1, 2021
Anticipated
July 29, 2018
August 8, 2018
August 14, 2018
Actual
January 29, 2019
January 31, 2019
Actual
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
No
No
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.
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).
Moyamoya Disease
revascularization
hemorrhagic moyamoya disease
Interventional
Not Applicable
Randomized
Parallel Assignment
Treatment
None (Open Label)
108
Anticipated
Conservative treatment
No Intervention
Conservative treatment. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, the prevention and treatment of secondary epilepsy, the control of intracranial hypertension(including the application of mannitol and glycerol fructose, etc.), and the corresponding symptomatic and neurotrophic treatment. Non-specific treatment is mainly deal with intracranial hematoma, including intraventricular drainage, intracranial hematoma evacuation, and ventriculoperitoneal shunt.
Indirect vascular reconstruction surgery
Experimental
Indirect vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) is performed. The surgery is performed according to the procedures described by Matsushima.
Procedure: Conservative treatment
direct vascular reconstruction surgery
Experimental
Direct vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) bypass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And if necessary, the STA may not be preserved. The bone flap should be large enough to select the right recipient blood vessel.
Procedure: Conservative treatment
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.
Indirect vascular reconstruction surgery
direct vascular reconstruction surgery
indirect revascularization
direct revascularization
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
Severe Disability
Cerebral infarction resulting in severe disability (mRS score≥3)
Through study completion, an average of 1 year
Severe Disability or Death
Severe disability or death caused by other reasons
Through study completion, an average of 1 year
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
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.
No
All
18 Years
Adult
Older Adult
Lian Duan, Chief
Contact
0086-10-66947156
keyan307@163.com
Lian Lian, Chief
The 307th Hospital of Military Chinese People's Liberation Army
Study Chair
The 307th Hospital of Military Chinese People's Liberation Army
Recruiting
Beijing
Beijing
100071
China
Lian Duan, Chief
Contact
No
February 26, 2021
D000009072
Moyamoya Disease
D000002340
Carotid Artery Diseases
D000002561
Cerebrovascular Disorders
D000001927
Brain Diseases
D000002493
Central Nervous System Diseases
D000009422
Nervous System Diseases
D000002539
Cerebral Arterial Diseases
D000020765
Intracranial Arterial Diseases
D000001157
Arterial Occlusive Diseases
D000014652
Vascular Diseases
D000002318
Cardiovascular Diseases
M10615
Moyamoya Disease
Moyamoya Disease
high
M4176
Carotid Artery Diseases
low
M4393
Cerebrovascular Disorders
low
M3786
Brain Diseases
low
M4325
Central Nervous System Diseases
low
M4371
Cerebral Arterial Diseases
low
M21105
Intracranial Arterial Diseases
low
M3046
Arterial Occlusive Diseases
low
M15983
Vascular Diseases
low
T3892
Moyamoya Disease
Moyamoya Disease
high
BC10
Nervous System Diseases
BC14
Heart and Blood Diseases
All
All Conditions
Rare
Rare Diseases
M236194
Xylometazoline
low
M9925
Mannitol
low
M7679
Glycerol
low
VaCoAg
Vasoconstrictor Agents
Resp
Respiratory System Agents
All
All Drugs and Chemicals
NaAg
Natriuretic Agents