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

Study Overview
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Brief Summary
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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
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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

Official Title
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14-3-3 η (Eta) Protein as a Marker of Disease Activity, Severity and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis.

Conditions
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Rheumatoid Arthritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Patients with RA classified according to the revised American College of Rheumatology (ACR)/EULAR RA classification criteria 2010 for RA. Age ≥ 18 years. Patients who are able and willing to give written informed consent. Disease duration more than one year Exclusion Criteria: Any other autoimmune disease rather than RA. Patients with any disease affecting the cardiovascular system other than RA. Patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rheumatoid arthritis patients<br>90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 | Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients<br>* assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)<br>* Other names: Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques);|
| control group<br>50 age and sex matched healthy controls. All | Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients<br>* assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)<br>* Other names: Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA