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NCT Number: NCT03546309

Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy

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.

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Key information

Conditions

Moyamoya Disease Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Pediatric Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

xunming Ji

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RIC group

Device

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

Other

Patients allocated to Medication group will accept medication treatment by professional neurologists

Primary outcomes

  1. the incidence of major neurologic complications

    Time frame: during the perioperative period

    Including transient ischemic attack, cerebral infarction, intracranial hemorrhage, and seizures.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Distal radial pulses

    Time frame: within 7 days after RIC treatment

    professional doctors will check the distal radial pulses

  9. 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.

  10. 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.

  11. Palpation for tenderness

    Time frame: within 7days after RIC treatment

    Professional doctors will check it.

  12. 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.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. the score of PSQI

    Time frame: 0-30 days

    The Pittsburgh Sleep Quality Index (PSQI) is a standardized questionnaire used to assess sleep quality and disturbances over a one-month time interval.

  21. the score of SNAP-IV

    Time frame: 0-30 days

    SNAP-IV (Swanson, Nolan, and Pelham Teacher and Parent Rating Scale) is a widely used assessment tool designed to evaluate behavioral and emotional problems in children and adolescents.

  22. cerebral perfusion status

    Time frame: 0-3 months

    cerebral perfusion status in the operation side at 3 months posttreatment as assessed by magnetic resonance perfusion

Study contacts

Contact information is provided by the study sponsor or research team.

Sijie Li, MD

CONTACT

[email protected]

+8613581610258

Xunming Ji, MD PhD

CONTACT

[email protected];

+8613911077166

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Beijing 302 Hospital

Registry information

Official study title

Safety and Efficacy of Remote Ischemic Conditioning in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy

Acronym: RIC-PMD

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 6, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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