NCT01592084已完成不适用
Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- survial(tracheostomy free,<23 hours on NIPPV, from enrollment)
研究概览
简要总结
The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators
- •Time from disease onset is less than three years
- •18 years of age
- •Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.
排除标准
- •Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day
- •Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc)
- •A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline
- •Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.
结局指标
主要结局
survial(tracheostomy free,<23 hours on NIPPV, from enrollment)
时间窗: 3years
Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point.
次要结局
- ALSFRS(measure of disability)(at first evaluation(time 0-T0) to six months (T6))
研究者
Sharon Halton
Research Coordinator
The Methodist Hospital Research Institute
研究点 (1)
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