Clinical trial NCT05619068: The Evolution and Prognosis of Moyamoya Disease
Official title: Imaging Investigation on the Evolution and Prognosis of Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moyamoya Disease
Revascularization
Cognitive Impairment
Functional Impairment
Keywords: Moyamoya disease
Revascularization
Cognitive impairment
Functional impairment
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2022-11-16
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients confirmed with Moyamoya disease.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Cognitive decline
timeFrame: 1-5 years
Secondary outcomes:
measure: Changes of functional connectivity
timeFrame: 1-5 years
measure: Changes of perfusion status
timeFrame: 1-5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Lou Xin, MD, PhD
role: STUDY_CHAIR
References: