Clinical Trials Logo
  1. Home
  2. Lung Diseases, Interstitial
  3. NCT05396469

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

Lung Diseases, Interstitial Clinical Trial

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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05396469
Study type Observational
Source Odense University Hospital
Contact
Status Completed
Phase
Start date June 10, 2022
Completion date June 2, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04119115 - Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
Active, not recruiting NCT04559581 - Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Recruiting NCT05151640 - INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Completed NCT02251964 - Rituximab in Interstitial Pneumonitis Phase 2/Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01442779 - Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Recruiting NCT05866198 - Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation N/A
Active, not recruiting NCT05321082 - A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) Phase 3
Completed NCT04016168 - Idiopathic Pulmonary Fibrosis and Serum Bank
Recruiting NCT00258583 - Dorothy P. and Richard P. Simmons Center for ILD Research Registry
Recruiting NCT05855109 - Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
Completed NCT05719233 - Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Recruiting NCT04159129 - Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
Completed NCT03313180 - A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis Phase 3
Completed NCT05065190 - A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis Phase 3
Completed NCT03136120 - Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
Recruiting NCT04930666 - BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Recruiting NCT05503030 - Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients