Using Thoracic Ultrasound to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Lung Diseases, Interstitial Clinical Trial

— AURORA  

Official title:

Using Thoracic Ultrasound in a Rheumatological Setting to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis: Protocol for a Cross-Sectional Diagnostic Test Accuracy Study. AURORA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396469
• Other study ID #: S-20210154
• Status: Completed
• Start date: June 10, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: June 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Pulmonary diseases are significant contributors to morbidity and mortality in patients with rheumatoid arthritis (RA). One of the most common pulmonary manifestation in RA is interstitial lung disease (RA-ILD). Consequently, RA-ILD may be prevalent in approximately 30% and clinically evident in about 10% of RA patients. Since the median survival for patients with manifest RA-ILD is only 6.6 years, feasible methods of detecting early RA-ILD are warranted.

Objectives: To determine the diagnostic accuracy of thoracic ultrasound (TUS), using a 14-zone protocol, for ILD in RA patients with respiratory symptoms by using chest high-resolution computed tomography (HRCT) as the reference standard. The secondary aim is to evaluate the diagnostic accuracy for the blood biomarkers surfactant protein-D (SP-D) and microfibrillar-associated protein 4 (MFAP4) in the detection of ILD in this group of patients.

Data collection: Participants will be included after signing the informed consent; data will be collected and stored in a REDCap database.

Eligibility criteria for participants and settings where data will be collected: Patients eligible for inclusion are consenting adults (≥18 years) diagnosed with RA (according to the 2010 ACR-criteria for RA) and respiratory symptoms indicating RA-ILD, based on the presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough and/or a residual pneumonia or a chest X-ray indicating interstitial abnormalities in the lung.

Whether participants form a consecutive, random or convenience series: Participants form a consecutive series of up to 80 individuals in total.

Description of the index test and reference standard: Patients suspected of having RA-ILD will undergo a 14 zone TUS as index test performed by a junior resident in rheumatology, who is certified by the European Respiratory Society in performing TUS assessment. The anonymised images will be stored, and scored by the junior resident and two senior rheumatologists, who have also received training in TUS, as well as a TUS and ILD experienced pulmonologist. Chest HRCT will be the gold standard, i.e. the ILD reference standard.

Estimates of diagnostic accuracy and their precision: The two basic measures for quantifying the diagnostic accuracy of the TUS (index) test are the sensitivity and specificity in comparison to the chest HRCT. Statistical tests will be conducted using the McNemar test for correlated proportions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible for inclusion are consenting adults (=18 years) diagnosed with RA, with presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough, residual pneumonia or a chest X-ray indicating interstitial lung disease. All patients must fulfil the 2010 criteria for RA. A diagnosis of COPD does not exclude the patient from the study.

Exclusion Criteria:

• Patients with other systemic autoimmune diseases than RA (except secondary Sjøgrens syndrome) will be excluded. Other exclusion criteria are; previous or active lung cancer, lung transplant recipients and patients with known ILD or congenital lung disease, as well as patients who have had an HRCT performed within 12 months prior to the inclusion date. Patients who are unwilling or unable to provide written informed consent will also be excluded (i.e. not eligible).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Diagnostic Test:
• National guideline treatment
All discovered diseases will recieve national guideline treatment and follow up

Locations

Country	Name	City	State
Denmark	Rheumatology Research Unit, Dept. of Rheumatology, OUH	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Torkell Ellingsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RA-ILD	Estimates of diagnostic accuracy and precision: The diagnostic accuracy of the TUS (index) test for interstitial lung disease in rheumatoid arthritis in comparison to the chest HRCT.	31.01.2024