NCT07760662 Oxidative Stress and Cardiovascular Risk in Patients With Rheumatoid Arthritis
| NCT ID | NCT07760662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of La Laguna |
| Condition | Rheumatoid Arthritis (RA |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-01-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07760662 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis (RA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07760662 currently recruiting?
Yes, NCT07760662 is actively recruiting participants. Contact the research team at iferraza@ull.edu.es for enrollment information.
Where is the NCT07760662 trial being conducted?
This trial is being conducted at Santa Cruz de Tenerife, Spain.
Who is sponsoring the NCT07760662 clinical trial?
NCT07760662 is sponsored by University of La Laguna. The trial plans to enroll 200 participants.
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