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Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05938244
Collaborator
(none)
34
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    34 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Cardiac and Pulmonary Assessment in Egyptian Patients With Rheumatoid Arthritis and Their Correlation With Disease Activity
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. To determine cardiac and pulmonary involvement in RA patients [1 year]

      By using spirometry, echocardiography

    Secondary Outcome Measures

    1. To assess the correlation between cardiopulmonary findings in RA patients with disease activity [1 year]

      Using DAS28 as a measurement tool for activity

    2. To compare between diaphragmatic ultrasonography and PFT i.e. spirometry as a screening tool for restrictive pulmonary disorders [1 year]

      Using diaphragmatic ultrasonography and pulmonary function test

    3. To assess correlation between anterior chest wall ultrasound and pulmonary function test in RA patients [1 year]

      Anterior chest wall musculoskeletal ultrasonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any patient satisfying 2010 ACR/ EULAR RA classification criteria
    Exclusion Criteria:
    • Patients with definite diagnosis for any other systemic autoimmune disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Sara F. Ahmed, Lecturer, Assiut University
    • Study Chair: Manal M. Hassanien, Assistent prof., Assiut University
    • Study Director: Samar H. Goma, Professor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yosra Yousif Mahmoud nasser, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05938244
    Other Study ID Numbers:
    • Cardiopulmonary RA
    First Posted:
    Jul 10, 2023
    Last Update Posted:
    Jul 10, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yosra Yousif Mahmoud nasser, Resident doctor, Assiut University
    cardiac pulmonary rheumatoid arthritis
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jul 10, 2023