NCT03271333已完成不适用
Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- composite criteria: forced vital capacity and CO diffusing capacity
研究概览
简要总结
Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systemic sclerosis
- •Diffuse Infiltrating Pneumonia
排除标准
- •infection
- •other lung diseases
- •non French native
结局指标
主要结局
composite criteria: forced vital capacity and CO diffusing capacity
时间窗: At 24 months
Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.
次要结局
- composite criteria: forced vital capacity and CO diffusing capacity(At 12 months)
研究者
研究点 (2)
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