Oxidative Stress and Cardiovascular Risk in Patients With Rheumatoid Arthritis

NCT07760662 | Recruiting

• 2 other identifiers: ULLPIFIISC23/07
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis (RA; Oxidative Stress; Cardiovascular (CV) Risk

Keywords

Rheumatoid arthritis; Oxidative stress

Outcome Measures

Primary Outcomes (3)

• Serum levels of Copper-Zinc Superoxide Dismutase

  Relationship between Serum levels of Copper-Zinc Superoxide Dismutase and rheumatoid arthritis features

  From January 2024 to December 2026

• Oxidative stress analytical measurement

  Serum levels of Copper-Zinc Superoxide Dismutase

  2 years

• Oxidative stress analytical values

  Copper-Zinc Superoxide Dismutase serum levels

  2 years

Study Arms (1)

Rheumatoid arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

RECRUITING

Related Publications (3)

• Valenzuela A. The biological significance of malondialdehyde determination in the assessment of tissue oxidative stress. Life Sci. 1991;48(4):301-9. doi: 10.1016/0024-3205(91)90550-u.

  PMID: 1990230 BACKGROUND

• Landi M. Commentary to: "Improving the thiobarbituric acid-reactive-substances assay for estimating lipid peroxidation in plant tissues containing anthocyanin and other interfering compounds" by Hodges et al., Planta (1999) 207:604-611. Planta. 2017 Jun;245(6):1067. doi: 10.1007/s00425-017-2699-3. Epub 2017 Apr 29. No abstract available.

  PMID: 28456836 BACKGROUND

• Kikugawa K, Kojima T, Yamaki S, Kosugi H. Interpretation of the thiobarbituric acid reactivity of rat liver and brain homogenates in the presence of ferric ion and ethylenediaminetetraacetic acid. Anal Biochem. 1992 May 1;202(2):249-55. doi: 10.1016/0003-2697(92)90102-d.

  PMID: 1519749 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ivan Ferraz, MD

CONTACT

+34647868518; iferraza@ull.edu.es

Elsa Oramas

CONTACT

+34922678502; elsaoramas@yahoo.es

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: January 1, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

ES (1)