Oxidative Stress and Cardiovascular Risk in Patients With Rheumatoid Arthritis
Recruiting · NCT07760662 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of La Laguna
View the official record on ClinicalTrials.gov →What this trial is about
The pathogenic process underlying atherosclerosis resembles a chronic inflammatory response in which oxidative stress is involved. Similarly, oxidative stress is widely recognized to play an important role in the clinical course and pathogenesis of rheumatoid arthritis (RA). RA has been associated with accelerated atherosclerosis. This cross-sectional study will include patients with RA. The primary objective is to evaluate the association between selected oxidative stress biomarkers-serum malondialdehyde levels, superoxide dismutase, and glutathione peroxidase-and the presence of subclinical atherosclerosis and carotid arterial stiffness in patients with RA. We will subsequently assess whether these molecules are related to cardiovascular disease determinants, including inflammatory dyslipidemia, insulin resistance, and beta-cell dysfunction, which may occur in this condition. This study will further explore the relationship between oxidative stress and cardiovascular disease in RA.
Who can take part
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 is running
1 location listed.
- Hospital Universitario de Canarias - Santa Cruz de Tenerife, Canary Islands, Spain