NCT06531785

Brief Summary

The aim of this observational cross-sectional study is to assess accuracy of Lung Ultrasound to early diagnose ILD among Rheumatoid arthritis patients. Rheumatoid arthritis patients with suggestive history of chest troubles will be evaluated using chest ultrasound and high resolution CT chest to evaluate ability of chest ultrasound to early diagnose ILD among rheumatoid arthritis patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

July 29, 2024

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of rheumatoid arthritis patients that can be diagnosed early with Interstitial lung disease.

    early diagnosis of Interstitial lung disease among rheumatoid arthritis patients using chest ultrasound versus high resolution computed tomography

    1 month

Interventions

Lung ultrasound to early diagnose ILD among rheumatoid arthritis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age \> 18 years

You may qualify if:

  • Confirmed diagnosis of rheumatoid arthritis and suspicion of interstitial lung disease on history and/ or clinical examination, age \> 18 years

You may not qualify if:

  • Patients who refuse to participate in the study,
  • Patients with a history of pulmonary neoplasia or
  • Patients with causes of interstitial fluid, such as, heart failure, diastolic dysfunction, asthma or pulmonary edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

Location

Related Publications (3)

  • Tardella M, Di Carlo M, Carotti M, Filippucci E, Grassi W, Salaffi F. Ultrasound B-lines in the evaluation of interstitial lung disease in patients with systemic sclerosis: Cut-off point definition for the presence of significant pulmonary fibrosis. Medicine (Baltimore). 2018 May;97(18):e0566. doi: 10.1097/MD.0000000000010566.

    PMID: 29718851BACKGROUND
  • Ohno Y, Koyama H, Yoshikawa T, Seki S. State-of-the-Art Imaging of the Lung for Connective Tissue Disease (CTD). Curr Rheumatol Rep. 2015 Dec;17(12):69. doi: 10.1007/s11926-015-0546-8.

    PMID: 26483318BACKGROUND
  • Tardella M, Gutierrez M, Salaffi F, Carotti M, Ariani A, Bertolazzi C, Filippucci E, Grassi W. Ultrasound in the assessment of pulmonary fibrosis in connective tissue disorders: correlation with high-resolution computed tomography. J Rheumatol. 2012 Aug;39(8):1641-7. doi: 10.3899/jrheum.120104. Epub 2012 Jul 1.

    PMID: 22753655BACKGROUND

MeSH Terms

Conditions

Lung Diseases, InterstitialArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Waleed MD Gamal Elddin Khaleel, Ass. Prof.

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Chest Diseases

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations