Recruiting NCT06817434
Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Revascularization/Conservative management.
- Who it may be relevant to
- Registry conditions: Moyamoya Disease. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.
Interventions
- Drug Revascularization/Conservative management
Revascularization/Conservative management
Primary outcome measures
- Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke) [Time frame: 18 months during follow-up]
Secondary outcome measures (7)
- Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Structural Remodeling of the Internal Carotid Artery Terminal and Middle Cerebral Artery Wall at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
- Changes in Blood Lipid Levels at 12 and 18 Months After Treatment [Time frame: 12 and 18 months during follow-up]
Eligibility criteria
Inclusion criteria
- The imaging examination meets the diagnostic criteria for moyamoya disease;
- Sign the informed consent form;
- Age ≥18 years old;
- Baseline mRS score ≤2 points;
- The patient receives revascularization/conservative treatment;
- There is at least 1 imaging follow-up result.
Exclusion criteria
- Patients with atherosclerosis, autoimmune diseases, meningitis, Down syndrome, cranial trauma, or those who have undergone radioactive head irradiation, as these conditions may lead to secondary cerebrovascular disease and contribute to the development of Moyamoya syndrome;
- Individuals under the age of 18;
- Participants who refuse to take part in this study;
- Pregnant patients;
- Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;
- A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;
- Individuals with a history of coronary heart disease or previous cardiovascular and cerebrovascular surgical interventions, including cerebral revascularization, intracranial artery stent implantation, carotid artery stenting, endarterectomy, coronary artery bypass grafting, or coronary stent implantation;
- Allergies to contrast media;
- Patients with missing imaging data or whose image quality cannot be analyzed;
- Individuals who refuse or are unable to undergo imaging follow-up;
- Patients receiving other types of lipid-lowering drug treatments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT06817434 · KY2023-297-02