- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531785
Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Asyut, Egypt, 711111
- Faculty of Medicine, Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of rheumatoid arthritis patients that can be diagnosed early with Interstitial lung disease.
Time Frame: 1 month
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early diagnosis of Interstitial lung disease among rheumatoid arthritis patients using chest ultrasound versus high resolution computed tomography
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waleed MD Gamal Elddin Khaleel, Ass. Prof., Assiut University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WGE72024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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