Clinical trial NCT04937140: Assessment of 14-3-3 η (Eta) Protein Antibodies in the Serum of Rheumatoid Arthritis Patients and Its Relation to Atherosclerosis.
Official title: 14-3-3 η (Eta) Protein as a Marker of Disease Activity, Severity and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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:

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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.

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: In the Medical Administration Sohag University
name: doaa adel, specialist
role: PRINCIPAL_INVESTIGATOR
References: