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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04937140
• Other study ID #: Soh-Med-21-06-11
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: June 2021
• Source: Sohag University
• Contact: doaa adel, specialist
• Phone: 01201786669
• Email: doaa_adel_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Atherosclerosis
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? (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"