Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis

NCT ID: NCT05938244

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-06-30

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)

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

case/ diseased patients

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

No interventions assigned to this group

control/ normal population

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yosra Yousif Mahmoud nasser

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara F. Ahmed, Lecturer

Role: STUDY_CHAIR

Assiut University

Manal M. Hassanien, Assistent prof.

Role: STUDY_CHAIR

Assiut University

Samar H. Goma, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Yosra Y. Mahmoud

Role: CONTACT

yoyomynmy@gmail.com

+201140408392

References

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Reference Type: BACKGROUND

PMID: 23335586 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34164156 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33609792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24907149 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26472415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29238722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31567944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27964793 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

Cardiopulmonary RA

Identifier Type: -

Identifier Source: org_study_id