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NCT Number: NCT06738264

Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )

The goal of this observational study is to learn about the long-term effects rheumatoid arthritis (RA) on cardiovascular system. The main question it aims to answer is:

Does seropositive raise risk of cardiovascular diseases more than seronegative RA ?

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Key information

About this study

We will investigate cardiovascular risk factors in patients with seronegative and seropositive rheumatoid arthritis.

Complete clinical examination including blood pressure (BP; using an automatic BP monitor) and heart rate (in beats per minute (bpm) either from an automatic BP monitor or a 12 lead ECG) will be measured according to the standard hospital procedures.

Routine Laboratory investigations, including complete blood count (CBC), Blood parameters, including autoantibodies and lipid profile will be determined), liver and kidney function tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and lipid profile panel will be recorded.

The disease activity score-28 (DAS-28) and health assessment questionnaire (HAQ) will be assessed.

Framingham risk score will be calculated. Carotid doppler will be done . Current medications use including synthetic disease-modifying anti-rheumatic drugs (DMARDs), in addition to steroids, will be recorded.

Rheumatoid Factor and Anticitrullinated proteins antibodies presence will be determined.

Cardiovascular risk factors, including inflammation, hypertension, smoking, obesity, and dyslipidemia will be observed and a higher risk of Cardiovascular Diseases events (including myocardial infarction, stroke, and heart failure).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥ 18 years.
  • Both sexes.
  • All patients with RA confirmed using the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology EULAR classification criteria
  • RA diagnosed for at least six months to ensure chronicity.

Exclusion criteria

  • Diagnosis of other significant autoimmune diseases (e.g., lupus, scleroderma).
  • Use of medications known to significantly affect cardiovascular outcomes (e.g., certain anticoagulants or anti-inflammatory agents) that are not part of standard RA treatment.

Treatment and study plan

Primary outcomes

  1. carotid artery wall thickness

    Time frame: one week

    abnormality in carotid doppler

Study contacts

Contact information is provided by the study sponsor or research team.

amna mohamed ameen

CONTACT

[email protected]

01010283972

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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