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The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease (RIC-PMD-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821181
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
307 Hospital of PLA
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Brief Summary:
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.

Condition or disease Intervention/treatment Phase
Moyamoya Disease TIA Children Stroke Device: RIC group Device: Sham group Not Applicable

Detailed Description:
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial
Estimated Study Start Date : December 8, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.
Device: 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.

Sham Comparator: sham group
patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
Device: Sham group
patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.




Primary Outcome Measures :
  1. The incidence rate of transient ischemic attack(TIA) [ Time Frame: during baseline to 12months after therapy ]
    TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  2. The incidence rate of ischemic stroke [ Time Frame: during baseline to 12months after therapy ]
    Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.


Secondary Outcome Measures :
  1. Cerebral perfusion [ Time Frame: change from baseline to 12months after therapy ]
    cerebral perfusion status in the operation side at 12 months posttreatment as assessed by single photon emission computed tomography (SPECT).

  2. The mean blood flow velocity of cerebral vascular detected by TCCD [ Time Frame: changes form baseline to 6months,12months after therapy ]
    TCCD means tran-scranial color-coded duplex sonography.

  3. The score of National Institute of Health stroke scale score [ Time Frame: during baseline to 12months after therapy ]
    National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.The NHISS will be assessed by certified study investigator, who is blinded to the treatment assignment.

  4. The score of Modified Rankin scale score [ Time Frame: during baseline to 12months after therapy ]
    The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). The investigators will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment.

  5. Incidence rate of symptomatic intracerebral hemorrhage [ Time Frame: during baseline to 12months after therapy ]
    Symptomatic intracranial hemorrhage, including any subarachnoid hemorrhage associated with clinical symptoms and symptomatic intracerebral hemorrhage. Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  6. The number of cerebral lacunar infarction [ Time Frame: changes from baseline to 12months after therapy ]
    magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  7. The volume of cerebral lacunar infarction [ Time Frame: changes from baseline to 12 months after therapy ]
    magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  8. The rate of death and adverse event [ Time Frame: during baseline to 12months after therapy ]
    All causes of death will be included to compute mortality at 12 months after therapy

  9. Number of distal radial pulses [ Time Frame: changes from baseline to 6, 12months after therapy ]
    professional doctors will check the distal radial pulses

  10. Visual inspection of local edema of fundus oculi [ Time Frame: changes from baseline to 6, 12months after therapy ]
    Professional oculists will visually inspect the fundus oculi to evaluate whether there is local edema.

  11. The number of patients with erythema,and/or skin lesions related to RIC [ Time Frame: changes from baseline to 6, 12months after therapy ]
    Professional doctors will check it and the investigator will record the number.

  12. Palpation for tenderness [ Time Frame: changes from baseline to 6, 12months after therapy ]
    Professional doctors will definite whether there's a palpation for tenderness

  13. The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: during baseline to 12months after therapy ]
    The investigator will record the number.

  14. The number of patients with any other adverse events related to RIC intervention [ Time Frame: during baseline to 12months after therapy ]
    The investigator will record the number.

  15. The score of ABCD2 [ Time Frame: during baseline to 12months after therapy ]
    When subjects are diagnosed as TIA within 12 months after therapy ,The investigators use this scale to evaluate the patients' risk of stroke who with TIA .The score of the scale ranges from 0 to 7, and the higher score indicates higher risk of stroke in the patients who with TIA.The scale will be assessed by qualified investigator who are blinded to the treatment assignment.

  16. The level of S-100A4 [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  17. The level of matrix metalloproteinase 9 (MMP-9) [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  18. The level of basic fibroblast growth factor [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  19. The level of platelet derived growth factor [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  20. The level of vascular endothelial growth factor [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  21. The level of hs-CRP(high-sensitive C-reactive protein) [ Time Frame: change from baseline (pre‑RIC treatment) to 6 months ,12 months after therapy ]
    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

  22. cerebral perfusion examined by SPECT [ Time Frame: from baseline(pre-RIC treatment) to 12 months after therapy ]
    cerebral perfusion status post-treatment will be assessed by single photon emission computed tomography (SPECT).

  23. cerebral perfusion examined by ASL [ Time Frame: from baseline(pre-RIC treatment) to 12 months after therapy ]
    cerebral perfusion status post-treatment will be assessed by arterial spin labeling(ASL)

  24. variant of the RNF-213 gene [ Time Frame: from baseline(pre-RIC treatment) to 12 months after therapy ]
    The investigators will save the blood sample in -20℃,and detect the variant RNF-213 gene



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥0 and ≤18
  • all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012
  • The CVR of patients detected by SPECT is not impaired severely
  • The patients didn't suffer stroke before.
  • Informed consent obtained from patient or acceptable patient's surrogate

Exclusion Criteria:

  • Severe hepatic or renal dysfunction
  • Severe hemostatic disorder or severe coagulation dysfunction
  • Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull‑base radiation therapy
  • Any of the following cardiac disease ‑ rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
  • Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
  • Patient participating in a study involving other drug or device trial study
  • Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations
  • Unlikely to be available for follow‑up for 3 months
  • Contraindication for RIC ‑ severe soft‑tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821181


Contacts
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Contact: Xunming Ji, MD PhD 108613911077166 Jixunming@vip.163.com;
Contact: Sijie Li, MD 1083199439 phoenix0537@sina.com

Locations
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China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Capital Medical University
307 Hospital of PLA
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Responsible Party: Ji Xunming,MD,PhD, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03821181    
Other Study ID Numbers: RIC-PMD-1
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Xunming,MD,PhD, Capital Medical University:
pediatric moyamoya disease
TIA
Stroke
Remote ischemic conditioning
Additional relevant MeSH terms:
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Stroke
Moyamoya Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases