Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Sicurezza ed efficacia del RIC nei pazienti pediatrici con malattia di Moyamoya trattati con terapia di rivascolarizzazione (RIC-PMD)

11 novembre 2026 aggiornato da: Ji Xunming,MD,PhD, Capital Medical University

Sicurezza ed efficacia del condizionamento ischemico remoto nei pazienti pediatrici con malattia di Moyamoya trattati con terapia di rivascolarizzazione

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

98

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Xunming Ji, MD PhD
  • Numero di telefono: +8613911077166
  • Email: 807595234@qq.com;

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina
        • Reclutamento
        • The Fifth Medical Center of Chinese PLA General Hospital
        • Contatto:
          • xunming Ji

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Altro: Medication group

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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
the incidence of major neurologic complications
Lasso di tempo: during the perioperative period

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The score of National Institute of Health stroke scale score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: within 7days after RIC treatment

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Capital Medical University

Collaboratori

Beijing 302 Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2024

Completamento primario (Stimato)

18 novembre 2026

Completamento dello studio (Stimato)

18 novembre 2026

Date di iscrizione allo studio

Primo inviato

12 marzo 2018

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2018

Primo Inserito (Effettivo)

6 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RIC-PMD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi