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Sikkerhed og effektivitet af RIC hos pædiatriske patienter med Moyamoya-sygdom behandlet med revaskulariseringsterapi (RIC-PMD)

11. november 2026 opdateret af: Ji Xunming,MD,PhD, Capital Medical University

Sikkerhed og effektivitet af fjern iskæmisk konditionering hos pædiatriske patienter med Moyamoya-sygdom behandlet med revaskulariseringsterapi

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

98

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • The Fifth Medical Center of Chinese PLA General Hospital
        • Kontakt:
          • xunming Ji

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andet: Medication group

Patients allocated to the medication group will accept medication treatment by professional neurologists.
Andet: Medication group

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the incidence of major neurologic complications
Tidsramme: during the perioperative period

Including transient ischemic attack, cerebral infarction, intracranial hemorrhage, and seizures.
during the perioperative period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The score of National Institute of Health stroke scale score
Tidsramme: 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.
change from baseline (preoperation) at 24 hours, 48 hours, 72 hours, and at 5-7 days or if discharged earlier
The score of Modified Rankin scale score
Tidsramme: 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
change from baseline (pre-RIC treatment) at 180 days after revascularization therapy
Symptomatic intracerebral hemorrhage
Tidsramme: 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.
during the first 180 days after revascularization therapy
Incidence of new infarct in brain
Tidsramme: 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.
during 72 hours and 180 days after revascularization therapy
Angiographic outcome
Tidsramme: 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.
180 days after revascularization therapy
Death and adverse event
Tidsramme: 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.
180 days after revascularization therapy
Infarct volume in brain
Tidsramme: during 72 hours and 180 days after revascularization therapy

Head MRI is a precise method which is commonly used to evaluate infarct size.
during 72 hours and 180 days after revascularization therapy
Distal radial pulses
Tidsramme: within 7 days after RIC treatment

professional doctors will check the distal radial pulses
within 7 days after RIC treatment
Visual inspection for local edema
Tidsramme: within 7days after RIC treatment

Professional oculists will check the fundus oculi to evaluate whether there is local edema.
within 7days after RIC treatment
The number of patients with erythema,and/or skin lesions related to RIC
Tidsramme: within 7days after RIC treatment

Professional doctors will check it and the investigator will record the number.
within 7days after RIC treatment
Palpation for tenderness
Tidsramme: within 7days after RIC treatment

Professional doctors will check it.
within 7days after RIC treatment
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
Tidsramme: within 7days after RIC treatment

The investigator will record the number.
within 7days after RIC treatment
The number of patients with any other adverse events related to RIC intervention
Tidsramme: within 7days after RIC treatment

The investigator will record the number.
within 7days after RIC treatment
The score of ABCD2
Tidsramme: 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
change from baseline (pre-RIC treatment) at 180 days after revascularization therapy
The level of S-100A4
Tidsramme: 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
change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months postoperation
The level of matrix metalloproteinase 9 (MMP-9)
Tidsramme: 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
change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation
The level of basic fibroblast growth factor
Tidsramme: 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
change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation
The level of platelet derived growth factor
Tidsramme: 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
change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation
The level of vascular endothelial growth factor
Tidsramme: 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
change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation
the score of PSQI
Tidsramme: 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.
0-30 days
the score of SNAP-IV
Tidsramme: 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.
0-30 days
cerebral perfusion status
Tidsramme: 0-3 months

cerebral perfusion status in the operation side at 3 months posttreatment as assessed by magnetic resonance perfusion
0-3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Capital Medical University

Samarbejdspartnere

Beijing 302 Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. september 2024

Primær færdiggørelse (Anslået)

18. november 2026

Studieafslutning (Anslået)

18. november 2026

Datoer for studieregistrering

Først indsendt

12. marts 2018

Først indsendt, der opfyldte QC-kriterier

3. juni 2018

Først opslået (Faktiske)

6. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RIC-PMD

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