Oxidative Stress and Heart Risk in People with Rheumatoid Arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cross-sectional study will enroll adults with rheumatoid arthritis to examine whether serum oxidative stress markers—malondialdehyde, superoxide dismutase, and glutathione peroxidase—are associated with subclinical atherosclerosis and carotid arterial stiffness. The research will also explore how these molecules relate to cardiovascular risk factors such as inflammatory lipid changes, insulin resistance, and beta-cell function. The investigation aims to better understand how oxidative stress may contribute to cardiovascular disease in RA. No interventional treatment is being tested, and the study will describe associations rather than causality. The lead site is Hospital Universitario de Canarias in Tenerife, with the University of La Laguna as sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men or women who are not pregnant or breastfeeding.
* Age 18 years or older and younger than 70 years.
* Treatment with any disease-modifying antirheumatic drug, including biologic therapies.
* For patients receiving oral corticosteroids, a prednisone dose of 10 mg or less that has remained stable for at least one month before study inclusion.
* Ability and willingness to provide written informed consent.

Exclusion Criteria:

* Autoimmune rheumatic disease other than RA, including systemic lupus erythematosus, mixed connective tissue disease, systemic sclerosis, or polymyositis. Sjögren syndrome associated with RA will not be an exclusion criterion.
* Functional class IV RA with complete or substantial disability, including confinement to bed or wheelchair that prevents personal self-care.
* History or current presence of inflammatory joint disease other than RA, such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, or Lyme disease.
* Estimated glomerular filtration rate below 60 mL/min/1.73 m² or active renal disease.
* Pregnancy or breastfeeding.
* Evidence of severe uncontrolled concomitant cardiovascular, neurological, pulmonary (including obstructive lung disease), renal, hepatic, endocrine (including diabetes mellitus), or gastrointestinal disease, or any condition considered by the investigator likely to alter the lipid profile.
* Body weight greater than 150 kg.
* History of alcoholism, drug abuse, or substance misuse within six months before the screening visit.
* Statin use will not be an exclusion criterion.

Where it's running

• Hospital Universitario de Canarias
  Santa Cruz de Tenerife, Canary Islands, Spain Recruiting

Study contacts

• Study coordinator: Ivan Ferraz, MD
• Email: iferraza@ull.edu.es
• Phone: +34647868518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.