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Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy (RIC-PMD)

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ClinicalTrials.gov Identifier: NCT03546309
Recruitment Status : Not yet recruiting
First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Capital Medical University

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE June 5, 2018
Last Update Posted Date June 5, 2018
Estimated Study Start Date  ICMJE June 30, 2018
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2018)
cerebral perfusion cerebral perfusion [ Time Frame: change from baseline(pre-RIC treatment) at 180 days after revascularization therapy ]
cerebral perfusion status in the operation side at 6 months posttreatment as assessed by single photon emission computed tomography (SPECT).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2018)
  • The score of National Institute of Health stroke scale score [ Time Frame: change from baseline (preoperation) at 24 hours, 48 hours, 72 hours, and at 5-7 days or if discharged earlier ]
    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 score of Modified Rankin scale score [ Time Frame: change from baseline (pre‑RIC treatment) at 180 days after revascularization 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). We 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, at 90 days postoperation. The distribution of mRS will be compared between groups
  • Symptomatic intracerebral hemorrhage [ Time Frame: during the first 180 days after revascularization 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.
  • Incidence of new infarct in brain [ Time Frame: during 72 hours and 180 days after revascularization therapy ]
    Head MRI is a precise method which is commonly used to evaluate weather there's new infarct in brain.
  • Angiographic outcome [ Time Frame: 180 days after revascularization therapy ]
    Angiographic outcome will be assessed following Matsushima's criteria (proportion of the middle cerebral artery territory with revascularization from collaterals from the external carotid artery through the burr holes): Grade A: >2/3; Grade B: between 1/3 and 2/3; Grade C: <1/3.
  • Death and adverse event [ Time Frame: 180 days after revascularization therapy ]
    All causes of death will be included to compute mortality at 180 days postoperation, and mortality will be compared between groups. Any adverse event will be reported and its relationship with the RIC intervention will be evaluated.
  • Infarct volume in brain [ Time Frame: during 72 hours and 180 days after revascularization therapy ]
    Head MRI is a precise method which is commonly used to evaluate infarct size.
  • Distal radial pulses [ Time Frame: within 7 days after RIC treatment ]
    professional doctors will check the distal radial pulses
  • Visual inspection for local edema [ Time Frame: within 7days after RIC treatment ]
    Professional oculists will check the fundus oculi to evaluate whether there is local edema.
  • The number of patients with erythema,and/or skin lesions related to RIC [ Time Frame: within 7days after RIC treatment ]
    Professional doctors will check it and the investigator will record the number.
  • Palpation for tenderness [ Time Frame: within 7days after RIC treatment ]
    Professional doctors will check it.
  • The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [ Time Frame: within 7days after RIC treatment ]
    The investigator will record the number.
  • The number of patients with any other adverse events related to RIC intervention [ Time Frame: within 7days after RIC treatment ]
    The investigator will record the number.
  • The score of ABCD2 [ Time Frame: change from baseline (pre‑RIC treatment) at 180 days after revascularization therapy ]
    We 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
  • The level of S-100A4 [ Time Frame: change from baseline (pre‑RIC treatment) at 7 days after RIC treatment, 24 (−6/+12) hours, 72 ± 6 hours and 6 months postoperation ]
    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 matrix metalloproteinase 9 (MMP-9) [ Time Frame: change from baseline (pre‑RIC treatment) at 7 days after RIC treatment, 24 (−6/+12) hours, 72 ± 6 hours and 6 months post-operation ]
    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 baseline (pre‑RIC treatment) at 7 days after RIC treatment, 24 (−6/+12) hours, 72 ± 6 hours and 6 months post-operation ]
    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 platelet derived growth factor [ Time Frame: change from baseline (pre‑RIC treatment) at 7 days after RIC treatment, 24 (−6/+12) hours, 72 ± 6 hours and 6 months post-operation ]
    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 baseline (pre‑RIC treatment) at 7 days after RIC treatment, 24 (−6/+12) hours, 72 ± 6 hours and 6 months post-operation ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
Official Title  ICMJE Safety and Efficacy of Remote Ischemic Conditioning in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
Brief Summary Revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric Moyamoya disease (MMD) patients with ischemic symptoms. However, perioperative complications, such as hyperperfusion syndrome, new infarct on imaging, or ischemic stroke, are inevitable. Remote ischemic conditioning (RIC) is a noninvasive and easy‑to‑use neuroprotective strategy, and it has potential effects on preventing hyperperfusion syndrome and ischemic infarction.
Detailed Description This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients undergoing revascularization surgery therapy, and this data will provide parameters for future larger scale clinical trials if efficacious.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Moyamoya Disease
  • Pediatric
Intervention  ICMJE
  • 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.
  • 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.
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.
    Intervention: Device: RIC group
  • 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.
    Intervention: Device: sham group
Publications *

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2018)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Suzuki stages concentrated in Stage III and IV
  • Presentation with ischemic symptoms, such as transient ischemic attack (TIA), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by MRI
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xunming Ji, MD PhD 861083198952 Jixunming@vip.163.com;
Contact: Sijie Li, MD 1083199439 phoenix0537@sina.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03546309
Other Study ID Numbers  ICMJE RIC-PMD
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
Plan to Share IPD: Undecided
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 June 2018

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