dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

Sponsor
University Hospital, Tours
Study ID
NCT06235645
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lung ultrasound (LUS) — DIAGNOSTIC_TEST
    If included, an LUS will be performed by an experienced operator, blinded to the results of the chest CT and PFT. A linear probe (4 to 12 MHz) will be used. The patient will be installed́ in a semi-seated position with the homolateral arm above the head for the anterior and axillary evaluation then, depending on his comfort, in a seated position or in right then left lateral decubitus, arms alongside the body, for the posterior evaluation. It will be practiced by experienced operators (pneumologist) and according to a validated protocol allowing the exploration of 14 intercostal spaces. LUT will be timed, recorded and anonymized. The operator will note the 3 ultrasound signs (total number of B lines, pleural line thickening and percentage of pleural line irregularity), their location and severity. The radiologist, on his part, will evaluate the patient's chest CT (gold standard), blinded to the results of the LUS, to make or not the diagnosis of RA-ILD.

Study Details

Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD). RA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients. The prevalence of RA-ILD varies according to the screening tool used. The current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established. Lung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF). LUS is a non-irradiating, non-expensive examination that can be performed rapidly. The aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.

Key Dates

First listed
Feb 1, 2024
Start date
Nov 18, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
280 participants (estimated)

Primary Outcome Measure

Determination sensitivity and specificity of thoracic ultrasound [ Time Frame: 2 years ]

Central Contacts

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