dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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 (pneumolo

Первичные конечные точки

• Determination sensitivity and specificity of thoracic ultrasound [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Percentage of each of the 3 ultrasound signs among pathological ultrasounds. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Adult patient (age > 18 years) followed at CHU of Tours
• Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis
• Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion
• Patient with at least two risk factors for developing RA-ILD among :

• Male sex or
• Active or former smoker assessed at 20 pack-year or
• Age > 60 years or
• Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or
• High RA activity score (DAS28>3.2)

Критерии исключения

• Diagnosis of congenital lung disease
• Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).
• Current or operated lung cancer
• Thoracic irradiation
• Thoracic transplant patients
• Previous invasive thoracic procedures
• Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)
• Pregnant or breast-feeding women
• Patient under legal protection (guardianship, curatorship or safeguard of justice)
• Patient who has objected to data processing
• Parenchymal infection current or less than one month old prior to LUS examination
• Liquid or gaseous pleural effusion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 1 центр

• university hospital Tours — Tours

Публикации

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• Dawson JK, Fewins HE, Desmond J, Lynch MP, Graham DR. Fibrosing alveolitis in patients with rheumatoid arthritis as assessed by high resolution computed tomography, chest radiography, and pulmonary function tests. Thorax. 2001 Aug;56(8):622-7. doi: 10.1136/thorax.56.8.622. PMID 11462065
• Matson S, Lee J, Eickelberg O. Two sides of the same coin? A review of the similarities and differences between idiopathic pulmonary fibrosis and rheumatoid arthritis-associated interstitial lung disease. Eur Respir J. 2021 May 13;57(5):2002533. doi: 10.1183/13993003.02533-2020. Print 2021 May. PMID 33303554

Идентификаторы

NCT: NCT06235645 · DR230226 - EARLIER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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