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

NCT05396469 | Completed DMC

• 1 other identifier: S-20210154
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis and Associated Conditions; Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

National guideline treatment DIAGNOSTIC_TEST

All discovered diseases will recieve national guideline treatment and follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients will be recruited from the Department of Rheumatology in the Hospital of South West Jutland, Odense University Hospital - Svendborg Hospital, Lillebaelt Hospital and Odense University Hospital (OUH). Patients coming inn for a planned control of their RA disease and management, will be asked if they have respiratory symptoms. If respiratory symptoms are present, the patient will receive oral information about this project and those who are interested in participating, will receive written information as well as a signed consent form (not yet to be signed). Subsequently, the patients will be referred to the highly specialized unit in the Department of Rheumatology at OUH as well as a full clinical evaluation in the PUlmo-REuma (PURE) Clinic located at OUH.

Sponsors & Collaborators

• Torkell Ellingsen: lead

Study Sites (1)

Rheumatology Research Unit, Dept. of Rheumatology, OUH

Odense, 5000, Denmark

Location

Related Publications (2)

• Sofiudottir BK, Harders S, Laursen CB, Lage-Hansen PR, Nielsen SM, Just SA, Christensen R, Davidsen JR, Ellingsen T. Detection of Interstitial Lung Disease in Rheumatoid Arthritis by Thoracic Ultrasound: A Diagnostic Test Accuracy Study. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1294-1302. doi: 10.1002/acr.25351. Epub 2024 Jun 23.

  PMID: 38622106 DERIVED

• Sofiudottir BK, Harders SMW, Lage-Hansen PR, Christensen R, Munk HL, Sorensen GL, Davidsen JR, Ellingsen T. Using thoracic ultrasound to detect interstitial lung disease in patients with rheumatoid arthritis: a protocol for the diagnostic test accuracy AURORA study. BMJ Open. 2022 Dec 23;12(12):e067434. doi: 10.1136/bmjopen-2022-067434.

  PMID: 36564119 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Torkell Ellingsen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Clin. Professor, Consultant

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: June 10, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 2, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 31.01.2024 - 31.01.2034
• Access Criteria: Data will be available on request for academic researchers.

Locations

DK (1)