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The Evolution and Prognosis of Moyamoya Disease

NCT ID: NCT05619068

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-12-31

Brief Summary

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To investigate the evolution of imaging appearances and cognitive function of Moyamoya disease (MMD) and to establish a prognosis evaluation system based on imaging biomarkers in MMD. The study may be helpful to optimize and improve the diagnosis and pretreatment assessment of MMD, and provide an important theoretical supplement to the existing guidelines for the management of MMD.

Detailed Description

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Moyamoya disease (MMD) is a chronic progressive cerebrovascular disease of unknown etiology. It is characterized by chronic progressive stenosis or occlusion of bilateral internal carotid arteries and abnormal puff vessels at the base of the brain. MMD is one of the important causes of cerebrovascular accident in young and middle-aged people, which leads to about 22% of stroke. With the development of neurosurgery, revascularization can effectively reduce the risk of stroke and other cerebrovascular accidents by increasing cerebral perfusion. Therefore, this project is expected to improve the diagnosis and pretreatment assessment of MMD from the traditional level of symptomatology to the level of brain cognitive function through new imaging methods and clinical approaches. The study of cognitive function changes in follow-up period or after revascularization, which is of great scientific significance for understanding the plasticity of cognitive function under different cerebral perfusion conditions, will also be conducted.

Conditions

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Moyamoya Disease Revascularization Cognitive Impairment Functional Impairment

Keywords

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Moyamoya disease Revascularization Cognitive impairment Functional impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medical treatment group

Conservative medical treatment

No interventions assigned to this group

Surgical treatment group

Direct revascularization, indirect revascularization or combined revascularization

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with MMD: Conventional angiography or MRI examination conforms to the Guidelines for Diagnosis and Treatment of MMD (Neurol Med Chir (Tokyo) 52, 245-266, 2012), It is characterized by stenosis or occlusion of the end of the internal carotid artery, anterior cerebral artery and/or the beginning of the middle cerebral artery of unknown cause, accompanied by dilatation of the perforating artery at the base of the brain or of capillaries on the surface of the brain, i.e., the formation of smoke vessels. Sign the informed consent. Older than 10 and younger than 60. The education level of patients reached primary school or above (years of education ≥6).

Exclusion Criteria

* Patients with massive cerebral infarction, multiple paraventricular ischemic foci, or significantly enlarged ventricular hydrocephalus after intracerebral hemorrhage. Patients with vascular diseases caused by immune system disease. Patients can not cooperate to complete the cognitive function test. There are other neuropsychiatric diseases that affect cognitive function (such as Alzheimer's disease, Parkinson's disease, depression, anxiety disorder, cerebral hemorrhage, hydrocephalus, craniocerebral trauma, etc.). Patients with contraindications of magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies) or unable to complete image collection.
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Lou

Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lou Xin, MD, PhD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinhao Lyu

Role: CONTACT

Phone: +8615903562929

Email: [email protected]

Facility Contacts

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Jinhao Lyu, MD

Role: primary

Other Identifiers

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MMD-301

Identifier Type: -

Identifier Source: org_study_id