Clinical trial NCT05938244: Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis
Official title: Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis and Their Correlation With Disease Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: cardiac pulmonary rheumatoid arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all Egyptian patients admitted to Assuit university hospitals with rheumatoid arthritis

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.

Detailed 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)

Eligibility criteria: Inclusion Criteria:

* Any patient satisfying 2010 ACR/ EULAR RA classification criteria

Exclusion Criteria:

* Patients with definite diagnosis for any other systemic autoimmune disorders

Primary outcomes:
measure: To determine cardiac and pulmonary involvement in RA patients
timeFrame: 1 year
Secondary outcomes:
measure: To assess the correlation between cardiopulmonary findings in RA patients with disease activity
timeFrame: 1 year
measure: To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders
timeFrame: 1 year
measure: To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Sara F. Ahmed, Lecturer
role: STUDY_CHAIR
affiliation: Assiut University
name: Manal M. Hassanien, Assistent prof.
role: STUDY_CHAIR
affiliation: Assiut University
name: Samar H. Goma, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
citation: Tekeli̇ AH. Pulmonary and cardiac involvement in patients with rheumatoid arthritis and ankylosing spondylitis. Eur Res J. 2023 Jan 14;1-10.
citation: 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.
citation: 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.
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.
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.
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.