NCT05938244

Brief Summary

To determine cardiac and pulmonary involvement in RA patients To assess the correlation between cardiopulmonary findings in RA patients with disease activity. To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders. To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

June 25, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

cardiac pulmonary rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • To determine cardiac and pulmonary involvement in RA patients

    By using spirometry, echocardiography

    1 year

Secondary Outcomes (3)

  • To assess the correlation between cardiopulmonary findings in RA patients with disease activity

    1 year

  • To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders

    1 year

  • To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients

    1 year

Study Arms (2)

case/ diseased patients

ultra sound anterior chest wall echocardiogram pulmonary function test diaphragmatic ultra sound lipid profile Rheumatoid factor Anti-ccp

control/ normal population

ultra sound anterior chest wall echocardiogram pulmonary function test diaphragmatic ultra sound lipid profile Rheumatoid factor Anti-ccp

Eligibility Criteria

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

all Egyptian patients admitted to Assuit university hospitals with rheumatoid arthritis

You may qualify if:

  • Any patient satisfying 2010 ACR/ EULAR RA classification criteria

You may not qualify if:

  • Patients with definite diagnosis for any other systemic autoimmune disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Rodriguez-Henriquez P, Solano C, Pena A, Leon-Hernandez S, Hernandez-Diaz C, Gutierrez M, Pineda C. Sternoclavicular joint involvement in rheumatoid arthritis: clinical and ultrasound findings of a neglected joint. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1177-82. doi: 10.1002/acr.21958.

    PMID: 23335586BACKGROUND
  • Hannawi SM, Hannawi H, Al Salmi I. Cardiovascular Risk in Rheumatoid Arthritis: Literature Review. Oman Med J. 2021 May 31;36(3):e262. doi: 10.5001/omj.2021.25. eCollection 2021 May.

    PMID: 34164156BACKGROUND
  • Figus FA, Piga M, Azzolin I, McConnell R, Iagnocco A. Rheumatoid arthritis: Extra-articular manifestations and comorbidities. Autoimmun Rev. 2021 Apr;20(4):102776. doi: 10.1016/j.autrev.2021.102776. Epub 2021 Feb 17.

    PMID: 33609792BACKGROUND
  • Choy E, Ganeshalingam K, Semb AG, Szekanecz Z, Nurmohamed M. Cardiovascular risk in rheumatoid arthritis: recent advances in the understanding of the pivotal role of inflammation, risk predictors and the impact of treatment. Rheumatology (Oxford). 2014 Dec;53(12):2143-54. doi: 10.1093/rheumatology/keu224. Epub 2014 Jun 6.

    PMID: 24907149BACKGROUND
  • Tekeli̇ AH. Pulmonary and cardiac involvement in patients with rheumatoid arthritis and ankylosing spondylitis. Eur Res J. 2023 Jan 14;1-10.

    BACKGROUND
  • Pinheiro FA, Souza DC, Sato EI. A Study of Multiple Causes of Death in Rheumatoid Arthritis. J Rheumatol. 2015 Dec;42(12):2221-8. doi: 10.3899/jrheum.150166. Epub 2015 Oct 15.

    PMID: 26472415BACKGROUND
  • Alunno A, Gerli R, Giacomelli R, Carubbi F. Clinical, Epidemiological, and Histopathological Features of Respiratory Involvement in Rheumatoid Arthritis. Biomed Res Int. 2017;2017:7915340. doi: 10.1155/2017/7915340. Epub 2017 Nov 7.

    PMID: 29238722BACKGROUND
  • Salaffi F, Carotti M, Di Carlo M, Tardella M, Giovagnoni A. High-resolution computed tomography of the lung in patients with rheumatoid arthritis: Prevalence of interstitial lung disease involvement and determinants of abnormalities. Medicine (Baltimore). 2019 Sep;98(38):e17088. doi: 10.1097/MD.0000000000017088.

    PMID: 31567944BACKGROUND
  • Kelly C, Iqbal K, Iman-Gutierrez L, Evans P, Manchegowda K. Lung involvement in inflammatory rheumatic diseases. Best Pract Res Clin Rheumatol. 2016 Oct;30(5):870-888. doi: 10.1016/j.berh.2016.10.004. Epub 2016 Nov 9.

    PMID: 27964793BACKGROUND
  • Mortada MA, Abdelrahman FI, Abdul-Sattar A, Mansour W. Relation between pulmonary function tests and ultrasonographic changes of asymptomatic anterior chest wall joints in rheumatoid arthritis patients. Egypt J Bronchol. 2022 Dec;16(1):8.

    BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sara F. Ahmed, Lecturer

    Assiut University

    STUDY CHAIR
  • Manal M. Hassanien, Assistent prof.

    Assiut University

    STUDY CHAIR
  • Samar H. Goma, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Yosra Y. Mahmoud

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 10, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share