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

June 15, 2021 updated by: Doaa Adel Ibrahim, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will include 90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 in addition to 50 age and sex matched healthy controls.

All the patients will be recruited from Rheumatology and Rehabilitation outpatient clinic in Sohag University Hospitals, Faculty of Medicine .

Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rheumatoid arthritis patients
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
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)
Other Names:
  • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)
control group
50 age and sex matched healthy controls. All
Diagnostic test: 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)
Other Names:
  • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)

What is the study measuring?

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
Time Frame: 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
through study completion, an average of 1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: doaa adel, specialist, In the Medical Administration Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-06-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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