NCT05396469: AURORA

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

Completed Last updated 18 June 2023

What this trial tests

trial testing National guideline treatment in Rheumatoid Arthritis and Associated Conditions in 80 participants. Completed in 2 June 2023.

Timeline

10 June 2022

Primary endpoint
15 May 2023

2 June 2023

Quick facts

Lead sponsor	Torkell Ellingsen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	10 June 2022
Primary completion	15 May 2023
Estimated completion	2 June 2023
Sites	1 location across Denmark

Drugs / interventions tested

• National guideline treatment

Conditions studied

• Rheumatoid Arthritis and Associated Conditions — all drugs for Rheumatoid Arthritis and Associated Conditions →
• Lung Diseases, Interstitial — all drugs for Lung Diseases, Interstitial →

Sponsor

Torkell Ellingsen

Who can join

18 and older, any sex, with Rheumatoid Arthritis and Associated Conditions or Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Using thoracic ultrasound to detect interstitial lung disease in patients with rheumatoid arthritis: a protocol for the diagnostic test accuracy AURORA study.
   Sofíudóttir BK, Harders SMW, Lage-Hansen PR, Christensen R, et al · · 2022 · cited 7× · PMID 36564119 · DOI 10.1136/bmjopen-2022-067434