Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Myasthenia gravis foundation of America post intervention status
研究概览
简要总结
The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.
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
- 0 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fluctuating muscle weakness and fatigability, along with one of the below:
- •more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
- •anti-AChR or MuSK antibody positivity;
- •positive to the neostigmine test;
- •understanding and assigning the informed consent form, and having a good compliance with the follow up.
排除标准
- •excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
- •poor compliance to the follow up.
结局指标
主要结局
Myasthenia gravis foundation of America post intervention status
时间窗: 3 years
Myasthenia gravis foundation of America post intervention status (PIS) is assessed by the investigators during follow up. According to history inquiry and physical examination, participants are rated as clinical remission (no complain of myasthenia, no weakness at physical examination, and no therapies concerning MG for one year), pharmocological remission (no complain of myasthenia, no weakness at physical examination, but undertaking MG therapies at the last year), minimal manifestation (no complain of weakness, but showing weakness at physical examination), improvement (symptoms and signs), unchanged (symptoms and signs) , worsening(symptoms and signs), exacerbation(symptoms and signs), and death (medical record).
次要结局
- Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at the follow up(Baseline, 1 year, 2 year, and 3 year)
- Change From Baseline in Activities of Daily Living (ADL) Scores at the follow up(Baseline, 1 year, 2 year, and 3 year)
- Change From Baseline in Myasthenia Gravis-Quality of Life Questionnaire-15 item (MG-QOL15) Scores at the follow up(Baseline, 1 year, 2 year, and 3 year)