dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Male sex or
Disqualifiers
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
Trial population
Adult patients followed at CHU de Tours with a diagnosis of rheumatoid arthritis and with at least two risk factors for developing PR-PID
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Lung ultrasound (LUS)
Diagnostic testIf 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Determination sensitivity and specificity of thoracic ultrasound
The primary outcome is to determine the sensitivity and specificity of thoracic ultrasound defined as pathological by a total number of B lines ≥ 9 and/or pleural line thickening ≥ 3mm and/or a percentage of pleural line irregularity ≥ 24%.
Time frame
2 yearsSecondary outcomes
1
Percentage of each of the 3 ultrasound signs among pathological ultrasounds.
The secondary outcome is the percentage of each of the 3 ultrasound signs among pathological ultrasounds.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov