NCT06817434招募中不适用
Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2024年12月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)
时间窗: 18 months during follow-up
The occurrence of cerebrovascular events, including TIA, ischemic stroke, or hemorrhagic stroke, will be assessed over an 18-month follow-up period.
次要结局
- Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment(12 and 18 months during follow-up)
- Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment(12 and 18 months during follow-up)
- Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment(12 and 18 months during follow-up)
- Changes in Blood Lipid Levels at 12 and 18 Months After Treatment(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(12 and 18 months during follow-up)
- Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment(12 and 18 months during follow-up)
- Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment(12 and 18 months during follow-up)
研究者
研究点 (1)
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