Clinical trial NCT06817434: Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
Official title: Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moyamoya Disease
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria.

Brief summary: The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

1. The imaging examination meets the diagnostic criteria for moyamoya disease;
2. Sign the informed consent form;
3. Age ≥18 years old;
4. Baseline mRS score ≤2 points;
5. The patient receives revascularization/conservative treatment;
6. There is at least 1 imaging follow-up result.

Exclusion Criteria:

1. 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;
2. Individuals under the age of 18;
3. Participants who refuse to take part in this study;
4. Pregnant patients;
5. Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;
6. A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;
7. 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;
8. Allergies to contrast media;
9. Patients with missing imaging data or whose image quality cannot be analyzed;
10. Individuals who refuse or are unable to undergo imaging follow-up;
11. Patients receiving other types of lipid-lowering drug treatments.

Primary outcomes:
measure: Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)
timeFrame: 18 months during follow-up
Secondary outcomes:
measure: Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Structural Remodeling of the Internal Carotid Artery Terminal and Middle Cerebral Artery Wall at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
measure: Changes in Blood Lipid Levels at 12 and 18 Months After Treatment
timeFrame: 12 and 18 months during follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: