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临床试验/NCT04195789
NCT04195789已完成不适用

Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.

研究概览

简要总结

The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.

Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.

The investigators want to assess the lung ultrasound performance compared with the gold standard.

Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Men and women over the age of 18
  • With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
  • Never received any biotherapy or targeted therapy
  • Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)

排除标准

  • Refusal to participate in the study
  • Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
  • Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
  • Patient with signs of cardiac decompensation
  • Patient with pulmonary auscultation suggestive of PID
  • Pregnant or lactating woman
  • Psychiatric pathology seriously hindering understanding
  • Difficulty understanding oral French
  • Person deprived of liberty or under legal protection

结局指标

主要结局

Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.

时间窗: Month 12

To estimate the sensitivity and specificity of pulmonary ultrasound compared to CT scans in patients with rheumatoid arthritis consulting at the Lyon South Hospital Centre or the Edouard Herriot Hospital for the start-up of biotherapy or targeted therapy. (CT : computerized tomography)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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