Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis and Their Correlation With Disease Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05938244
• Other study ID #: Cardiopulmonary RA
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Yosra Y. Mahmoud
• Phone: +201140408392
• Email: yoyomynmy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with systemic manifestations targeting primarily synovial joints and periarticular tissues, with a 1-3% prevalence, it is the most prevalent form of inflammatory arthritis.(1,2) Although synovitis is the pathological hallmark of RA, numerous extra-articular symptoms and comorbidities are probably present.(3) Cardiovascular and pulmonary system diseases are the two main causes of death in RA patients, and their symptoms are the most serious.(2,3) Patients with RA have a 50% greater risk of CV mortality and a two-fold increased risk of myocardial infarction, which is the most common cause of death in this population. (4) Echocardiographic examination is considered a good predictive tool for some cardiac conditions with early findings while no clinical signs is yet found on these patients. (5) The second major cause of death in patients with RA is respiratory disease, which occurs in 30-40% of patients.(6) Sometimes the disease is silent until it has lung complications, which come before joint problems. RA may affect the lung interstitium, airways, and pleurae, while pulmonary vascular involvement is less frequent.(7) Diaphragmatic ultrasound can be used to determine the prevalence of interstitial lung disease involvement in RA as a restrictive disorder. The association between pulmonary function tests (PFTs), potential risk factors, and clinical correlation must be calculated.(8)(9) Anterior chest wall (ACW ) joints undergo joint changes and can be involved along the course of RA yet seems to be underestimated(1) Ultrasonography of ACW can detect those changes even before being clinically evident (10)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient satisfying 2010 ACR/ EULAR RA classification criteria

Exclusion Criteria:

• Patients with definite diagnosis for any other systemic autoimmune disorders

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

Tekeli? AH. Pulmonary and cardiac involvement in patients with rheumatoid arthritis and ankylosing spondylitis. Eur Res J. 2023 Jan 14;1-10.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine cardiac and pulmonary involvement in RA patients	By using spirometry, echocardiography	1 year
Secondary	To assess the correlation between cardiopulmonary findings in RA patients with disease activity	Using DAS28 as a measurement tool for activity	1 year
Secondary	To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders	Using diaphragmatic ultrasonography and pulmonary function test	1 year
Secondary	To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients	Anterior chest wall musculoskeletal ultrasonography	1 year