Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Bezpečnost a účinnost RIC u dětských pacientů s Moyamoyovou chorobou léčených revaskularizační terapií (RIC-PMD)

11. listopadu 2026 aktualizováno: Ji Xunming,MD,PhD, Capital Medical University

Bezpečnost a účinnost vzdáleného ischemického stavu u dětských pacientů s Moyamoyovou chorobou léčených revaskularizační terapií

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

98

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Xunming Ji, MD PhD
  • Telefonní číslo: +8613911077166
  • E-mail: 807595234@qq.com;

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Ne starší než 18 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Jiný: Medication group

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

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
the incidence of major neurologic complications
Časové okno: during the perioperative period

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The score of National Institute of Health stroke scale score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: within 7days after RIC treatment

The investigator will record the number.
within 7days after RIC treatment
The score of ABCD2
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 0-3 months

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Capital Medical University

Spolupracovníci

Beijing 302 Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. září 2024

Primární dokončení (Odhadovaný)

18. listopadu 2026

Dokončení studie (Odhadovaný)

18. listopadu 2026

Termíny zápisu do studia

První předloženo

12. března 2018

První předloženo, které splnilo kritéria kontroly kvality

3. června 2018

První zveřejněno (Aktuální)

6. června 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RIC-PMD

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit