NCT06041659

Brief Summary

Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

September 11, 2023

Last Update Submit

February 12, 2025

Conditions

Keywords

Moyamoya DiseaseCerebral NetworkCognitive FunctionAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Changes of brain functional network

    Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min

Secondary Outcomes (2)

  • Postoperative delirium

    Day1-5 after surgery

  • Electroencephalogram changes

    Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan Hospital of Capital Medical University.

You may qualify if:

  • Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery
  • Age between 18-65 years
  • Obtain written informed consent.

You may not qualify if:

  • Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination
  • Preoperative cranial imaging suggesting cerebral infarction lesion diameter \>15mm
  • Patients allergic to anesthetic drugs
  • Metal implants in the body
  • Undergoing other experimental drug or instrumentation trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shu Li

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

October 24, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

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