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出境医 / 临床实验 / The Safety and Efficacy of RIC on Adult Moyamoya Disease (RIC-AMD)

The Safety and Efficacy of RIC on Adult Moyamoya Disease (RIC-AMD)

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.

Condition or disease Intervention/treatment Phase
Moyamoya Disease Device: RIC Drug: Aspirin Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : November 10, 2020
Actual Study Completion Date : February 2, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: RIC group
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.
 Device: RIC
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.
Medication group
Patients allocated to Medication group will accept medication treatment by professional neurologists.
 Drug: Aspirin
patients will accept medication guided by neurologists
Outcome Measures
Primary Outcome Measures :
  1. improvement ratio of mean cerebral blood flow [ Time Frame: change from the baseline to12 months after treatment ]
    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 :
  1. incidence of ischemic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.

  2. incidence of transient ischemic attack [ Time Frame: from the baseline to 12 months after treatment ]
    TIA is diagnosed by patients' transient neurologic deficit

  3. incidence of hemorrhagic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    hemorrhagic stroke is diagnosed by head CT

  4. The level of matrix metalloproteinase 9 (MMP-9) [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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

  5. The level of vascular endothelial growth factor [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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

  6. The level of basic fibroblast growth factor [ Time Frame: change from the baseline to 3, 6 ,12 months after treatment ]
    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

  7. The rate of death and adverse event [ Time Frame: change from the baseline to 12 months after treatment ]
    All causes of death will be included to compute mortality at 12 months after therapy

  8. The number of patients with erythema,and/or skin lesions related to RIC [ Time Frame: change from the baseline to 12 months after treatment ]
    Professional doctors will check it and the investigator will record the number.

  9. The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: change from the baseline to 12 months after treatment ]
    the investigator will record the number.

  10. The rate of progression of stenosis or occlusion at Willis circle [ Time Frame: 12 months after therapy ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Capital Medical University
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date March 12, 2021
Actual Study Start Date  ICMJE July 15, 2019
Actual Primary Completion Date November 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2020) 		improvement ratio of mean cerebral blood flow [ Time Frame: change from the baseline to12 months after treatment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • cerebral blood flow [ Time Frame: change from the baseline to12 months after treatment ]
    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
  • perfusion status [ Time Frame: change from the baseline to 12 months after treatment ]
    perfusion status detected by Single-Photon Emission Computed Tomography
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2020)
  • incidence of ischemic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
  • incidence of transient ischemic attack [ Time Frame: from the baseline to 12 months after treatment ]
    TIA is diagnosed by patients' transient neurologic deficit
  • incidence of hemorrhagic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    hemorrhagic stroke is diagnosed by head CT
  • The level of matrix metalloproteinase 9 (MMP-9) [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 3, 6 ,12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    the investigator will record the number.
  • The rate of progression of stenosis or occlusion at Willis circle [ Time Frame: 12 months after therapy ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • incidence of ischemic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
  • incidence of transient ischemic attack [ Time Frame: from the baseline to 12 months after treatment ]
    TIA is diagnosed by patients' transient neurologic deficit
  • incidence of hemorrhagic stroke [ Time Frame: from the baseline to 12 months after treatment ]
    hemorrhagic stroke is diagnosed by head CT
  • wall area [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    wall area is detected by 3T high-resolution black blood vessel wall imaging
  • remodeling index [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    The ratio of vessel wall at maximal lumen narrowing to reference vessel. and the vessel wall is detected by 3T high-resolution black blood vessel wall
  • the degree of enhancement of vessel wall [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    grade 0, no enhancement; grade 1, mild enhancement, the signal intensity of vessel wall is less than that of the pituitary infundibulum ; and grade 2, strong enhancement, the signal intensity of contrast enhanced vessel wall is similar to or greater than that of the infundibulum. it was detected by 3T high-resolution black blood vessel wall
  • The level of matrix metalloproteinase 9 (MMP-9) [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 3, 6, 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 3, 6 ,12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    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 [ Time Frame: change from the baseline to 12 months after treatment ]
    he investigator will record the number.
  • the total length of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    the total length of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging
  • average length of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    average length of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging
  • the number of lenticulostriate arteries [ Time Frame: change from the baseline to 6, 12 months after treatment ]
    the number of lenticulostriate arteries is detected by 3T high-resolution black blood vessel wall imaging
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of RIC on Adult Moyamoya Disease
Official Title  ICMJE The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Moyamoya Disease
Intervention  ICMJE
  • Device: RIC
    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.
  • Drug: Aspirin
    patients will accept medication guided by neurologists
Study Arms  ICMJE
  • Experimental: RIC group
    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.
    Intervention: Device: RIC
  • Medication group
    Patients allocated to Medication group will accept medication treatment by professional neurologists.
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2020) 		30
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2019) 		60
Actual Study Completion Date  ICMJE February 2, 2021
Actual Primary Completion Date November 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012268
Other Study ID Numbers  ICMJE RIC-AMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji Xunming,MD,PhD, Capital Medical University
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Capital Medical University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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