Oxidative Stress and Cardiovascular Risk in Patients With Rheumatoid Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of La Laguna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The reference population comprises patients with RA fulfilling the 2010 American College of Rheumatology classification criteria who are treated at Hospital Universitario de Canarias, Santa Cruz de Tenerife, and Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain, including patients attending hospital outpatient clinics and referral-area services.
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Rheumatoid arthritis patients
Trial outcomes
Primary outcomes
1
Serum levels of Copper-Zinc Superoxide Dismutase
Relationship between Serum levels of Copper-Zinc Superoxide Dismutase and rheumatoid arthritis features
Time frame
From January 2024 to December 20262
Oxidative stress analytical measurement
Serum levels of Copper-Zinc Superoxide Dismutase
Time frame
2 years3
Oxidative stress analytical values
Copper-Zinc Superoxide Dismutase serum levels
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov