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Assessment of 14-3-3 η (Eta) Protein Antibodies in the Serum of Rheumatoid Arthritis Patients and Its Relation to Atherosclerosis.

S

Sohag University

Status

Unknown

Conditions

Rheumatoid Arthritis

Treatments

Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients

Study type

Observational

Funder types

Other

Identifiers

NCT04937140
Soh-Med-21-06-11

Details and patient eligibility

About

The aims of this study are: • To assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • To investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis.

Full description

All the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • Assessment of medical and rheumatologic history.

  • Careful general and musculoskeletal examination.
  • Assessment of disease activity will be performed using the Disease Activity Score (DAS28) including 28 tender and swollen joint count, ESR and visual analogue scale.
  • X-ray both hands and feet
  • Larsen Score
  • Assessment of Body Mass Index (BMI)
  • Laboratory investigations:
  • Complete blood count (CBC) • Rheumatoid factor (RF) by latex method • Anti citrullinated protein antibodies ACPA by enzyme-linked immunosorbent assay (ELISA) • 14-3-3 η (eta) protein by (ELISA) • Erythrocytic sedimentation rate (ESR) • Quantitative C-reactive protein (CRP) • fasting blood glucose • lipid profile • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ECG

Enrollment

140 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Inclusion criteria:

    1. Patients with RA classified according to the revised American College of Rheumatology (ACR)/EULAR RA classification criteria 2010 for RA.

    2. Age ≥ 18 years.

    3. Patients who are able and willing to give written informed consent.

    4. Disease duration more than one year

      Exclusion Criteria:

    <!-- -->
    1. Any other autoimmune disease rather than RA.
    2. Patients with any disease affecting the cardiovascular system other than RA.
    3. Patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.

Trial design

140 participants in 2 patient groups

rheumatoid arthritis patients
Description:
90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010
Treatment:
Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients
control group
Description:
50 age and sex matched healthy controls. All
Treatment:
Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients

Trial contacts and locations

0

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Central trial contact

doaa adel, specialist

Data sourced from clinicaltrials.gov

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