Clinical trial NCT06531785: Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Official title: Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age \> 18 years

Brief summary: The aim of this observational cross-sectional study is to assess accuracy of Lung Ultrasound to early diagnose ILD among Rheumatoid arthritis patients. Rheumatoid arthritis patients with suggestive history of chest troubles will be evaluated using chest ultrasound and high resolution CT chest to evaluate ability of chest ultrasound to early diagnose ILD among rheumatoid arthritis patients.

Detailed description: Interstitial lung disease (ILD) is a common complication of connective tissue disease (CTD) and a leading cause of morbidity and mortality. Thus, early diagnosis and treatment may improve the prognosis of patients with ILD.

High-resolution computed tomography (HRCT) is the gold standard for ILD diagnosis. It can detect the location and type of lesions through its high resolution. Unfortunately, it is hampered by high cost and potential risks associated with radiation exposure, especially for pregnant women.

Accordingly, finding a low-cost, non-invasive, and non-ionizing diagnostic method is necessary for ILD. Lung ultrasound (LUS) has all of these advantages and is an accessible bedside procedure. As a result, it is easily accepted by patients. Over the last 20 years, LUS has mainly been applied in CTD-ILD diagnosis, where it has shown high sensitivity and specificity. The assessment of ILD by LUS is determined by the number of B-lines, which appear as a comet tail signal and originate from the pleural line without fading to the edge of the screen.

The total number of B-lines was found to correlate well with the HRCT score. To assess the number of B-lines, previous studies used various scoring systems by designing different intercostal spaces (LIS), such as 72 LIS, 50 LIS, and 14 LIS. This study aims to assess Lung ultrasound as a screening tool for early interstitial lung disease in connective tissue disease patients.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age \> 18 years

Exclusion Criteria:

* Patients who refuse to participate in the study,
* Patients with a history of pulmonary neoplasia or
* Patients with causes of interstitial fluid, such as, heart failure, diastolic dysfunction, asthma or pulmonary edema.

Primary outcomes:
measure: Number of rheumatoid arthritis patients that can be diagnosed early with Interstitial lung disease.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Assiut University
Study officials:
affiliation: Assiut University
name: Waleed MD Gamal Elddin Khaleel, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tardella M, Di Carlo M, Carotti M, Filippucci E, Grassi W, Salaffi F. Ultrasound B-lines in the evaluation of interstitial lung disease in patients with systemic sclerosis: Cut-off point definition for the presence of significant pulmonary fibrosis. Medicine (Baltimore). 2018 May;97(18):e0566. doi: 10.1097/MD.0000000000010566.
citation: Ohno Y, Koyama H, Yoshikawa T, Seki S. State-of-the-Art Imaging of the Lung for Connective Tissue Disease (CTD). Curr Rheumatol Rep. 2015 Dec;17(12):69. doi: 10.1007/s11926-015-0546-8.
citation: Tardella M, Gutierrez M, Salaffi F, Carotti M, Ariani A, Bertolazzi C, Filippucci E, Grassi W. Ultrasound in the assessment of pulmonary fibrosis in connective tissue disorders: correlation with high-resolution computed tomography. J Rheumatol. 2012 Aug;39(8):1641-7. doi: 10.3899/jrheum.120104. Epub 2012 Jul 1.