The Safety and Efficacy of RIC on Adult Moyamoya Disease (RIC-AMD)
Primary Purpose
Moyamoya Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RIC
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Moyamoya Disease focused on measuring moyamoya disease, remote ischemic conditioning, cerebral blood flow
Eligibility Criteria
Inclusion Criteria:
- Age: 18-60 years
- All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
- mRs≤3
- Informed consent obtained from patient or acceptable patient's surrogate.
Exclusion Criteria:
- Patients with acute ischemic or hemorrhagic stroke within 3 months.
- Severe hepatic or renal dysfunction.
- Severe hemostatic disorder or severe coagulation dysfunction.
- Severe cardiac diseases.
- Patients with severe existing neurological or psychiatric disease
- Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
- Patients have been done or plan to accept revascularization surgery.
Sites / Locations
- Xuanwu Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
RIC group
Medication group
Arm Description
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. They will also accept medication treatment by professional neurologists.
Patients allocated to Medication group will accept medication treatment by professional neurologists.
Outcomes
Primary Outcome Measures
improvement ratio of mean cerebral blood flow
Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.
Secondary Outcome Measures
incidence of ischemic stroke
ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
incidence of transient ischemic attack
TIA is diagnosed by patients' transient neurologic deficit
incidence of hemorrhagic stroke
hemorrhagic stroke is diagnosed by head CT
The level of matrix metalloproteinase 9 (MMP-9)
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
The level of basic fibroblast growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
The rate of death and adverse event
All causes of death will be included to compute mortality at 12 months after therapy
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
the investigator will record the number.
The rate of progression of stenosis or occlusion at Willis circle
Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012268
Brief Title
The Safety and Efficacy of RIC on Adult Moyamoya Disease
Acronym
RIC-AMD
Official Title
The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.
Detailed Description
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.
Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya Disease
Keywords
moyamoya disease, remote ischemic conditioning, cerebral blood flow
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIC group
Arm Type
Experimental
Arm Description
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. They will also accept medication treatment by professional neurologists.
Arm Title
Medication group
Arm Type
Other
Arm Description
Patients allocated to Medication group will accept medication treatment by professional neurologists.
Intervention Type
Device
Intervention Name(s)
RIC
Intervention Description
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
patients will accept medication guided by neurologists
Primary Outcome Measure Information:
Title
improvement ratio of mean cerebral blood flow
Description
Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.
Time Frame
change from the baseline to12 months after treatment
Secondary Outcome Measure Information:
Title
incidence of ischemic stroke
Description
ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
Time Frame
from the baseline to 12 months after treatment
Title
incidence of transient ischemic attack
Description
TIA is diagnosed by patients' transient neurologic deficit
Time Frame
from the baseline to 12 months after treatment
Title
incidence of hemorrhagic stroke
Description
hemorrhagic stroke is diagnosed by head CT
Time Frame
from the baseline to 12 months after treatment
Title
The level of matrix metalloproteinase 9 (MMP-9)
Description
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time Frame
change from the baseline to 3, 6, 12 months after treatment
Title
The level of vascular endothelial growth factor
Description
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time Frame
change from the baseline to 3, 6, 12 months after treatment
Title
The level of basic fibroblast growth factor
Description
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time Frame
change from the baseline to 3, 6 ,12 months after treatment
Title
The rate of death and adverse event
Description
All causes of death will be included to compute mortality at 12 months after therapy
Time Frame
change from the baseline to 12 months after treatment
Title
The number of patients with erythema,and/or skin lesions related to RIC
Description
Professional doctors will check it and the investigator will record the number.
Time Frame
change from the baseline to 12 months after treatment
Title
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Description
the investigator will record the number.
Time Frame
change from the baseline to 12 months after treatment
Title
The rate of progression of stenosis or occlusion at Willis circle
Description
Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.
Time Frame
12 months after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-60 years
All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.
mRs≤3
Informed consent obtained from patient or acceptable patient's surrogate.
Exclusion Criteria:
Patients with acute ischemic or hemorrhagic stroke within 3 months.
Severe hepatic or renal dysfunction.
Severe hemostatic disorder or severe coagulation dysfunction.
Severe cardiac diseases.
Patients with severe existing neurological or psychiatric disease
Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
Patients have been done or plan to accept revascularization surgery.
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
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The Safety and Efficacy of RIC on Adult Moyamoya Disease
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