RecruitingNCT06235645

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

Sponsor

University Hospital, Tours

Enrollment

280 participants

Start Date

Nov 18, 2024

Study Type

OBSERVATIONAL

Conditions

Rheumatoid Arthritis Interstitial Lung Disease Thoracic Ultrasound Lung Ultrasound

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether lung ultrasound can detect early lung scarring (interstitial lung disease) in patients with rheumatoid arthritis (RA) — a risk that is higher in certain patients. It compares the ultrasound to standard CT scans and breathing tests. **You may be eligible if...** - You are over 18 years old and have been diagnosed with rheumatoid arthritis - You are scheduled to have (or have recently had) a chest CT scan and breathing tests as part of your standard care - You have at least two risk factors for lung complications, such as being male, being a smoker, being over 60, having high levels of RF or anti-CCP antibodies, or having high RA activity **You may NOT be eligible if...** - You have a congenital lung disease or another autoimmune condition linked to lung disease (e.g., lupus, systemic sclerosis, myositis) - You have current or previous lung cancer or have had chest radiation - You are pregnant or breastfeeding - You are under guardianship or legal protection Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTLung ultrasound (LUS)

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.