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

NCT ID: NCT04937140

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-09-30

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

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

rheumatoid arthritis patients

90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010

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

Intervention Type: DIAGNOSTIC_TEST

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)

control group

50 age and sex matched healthy controls. All

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

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)

Eligibility 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

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Adel Ibrahim

Specialist of Rheumatology & Rehabilitation In the Medical Administration Sohag Universit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

doaa adel, specialist

Role: PRINCIPAL_INVESTIGATOR

In the Medical Administration Sohag University

Central Contacts

doaa adel, specialist

Role: CONTACT

doaa_adel_post@med.sohag.edu.eg

01201786669

Other Identifiers

Soh-Med-21-06-11

Identifier Type: -

Identifier Source: org_study_id