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

• Conditions: Rheumatoid Arthritis
• Interventions: Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients

• Registration Number: NCT04937140
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Study Start: 2021-09
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
14-3-3 eta protein as measured by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness as determined by carotid doppler ultrasound	through study completion, an average of 1 year"	relation between presence of 14-3-3 η (eta)by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness and detection of plaques