NCT06235645

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with RA and who have risk factors for RA-ILD are regularly reassessed in a rheumatology day hospital. As part of their routine follow-up, and given the absence of recommendations on screening for RA-ILD in this population, chest CT and PFT (pulmonary function tests) are regularly performed at the request of the rheumatologist. Therefore, all patients meeting the inclusion criteria and having undergone chest CT and PFT in the 6 months preceding or following their rheumatology reassessment will be offered participation in the study. Participation in the study does not alter the patient's usual follow-up. Objective of the study: evaluate the sensitivity and specificity of thoracic ultrasound compare to the chest CT in patients with risk factors of developing RA-ILD. Design: This is a non-interventional, prospective, single-center, multidisciplinary study.

Conditions

• Rheumatoid Arthritis
• Interstitial Lung Disease
• Thoracic Ultrasound
• Lung Ultrasound

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lung 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.

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2024-02-01
• Last updated: 2024-11-25

Locations

1 site across 1 country: France