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NCT Number: NCT07772466

Atherosclerosis in Early Rheumatoid Arthritis Patients Using Atherogenic Index of the Plasma and Carotid Intima Media Thickness

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease primarily affecting the peripheral joints, yet its extra-articular burden particularly on the cardiovascular (CV) system has emerged as its most consequential long-term complication . Cardiovascular disease (CVD) accounts for 40% of all deaths in RA patients, making it the leading cause of mortality .This excess CV risk is estimated to be 1.5 to 2 times higher than in the general population .The overall CV risk conferred by RA has been linked in magnitude to that of diabetes mellitus, underscoring RA as an independent cardiovascular risk factor formally recognised in the 2021 European Society of Cardiology Guidelines on CVD prevention .

In this context, the non-invasive detection of preclinical atherosclerosis before the onset of clinical CV events has become clinical priority. Carotid intima-media thickness (CIMT), measured by high-resolution B-mode ultrasonography, is a well-validated surrogate marker of early structural arterial wall changes that independently predicts future myocardial infarction and stroke .Multiple studies have documented significantly elevated CIMT in RA patients compared with age- and sex-matched controls; studies found higher CIMT values across all age groups in RA, with values increasing in proportion to disease severity as assessed by the Disease Activity Score in 28 joints .

The atherogenic index of plasma (AIP) defined as the base-10 logarithm of the triglyceride-to-HDL-cholesterol ratio has emerged as a calculated composite biomarker reflecting lipoprotein particle atherogenicity, particularly the preponderance of small, dense LDL particles .A high AIP (>0.21) has been independently associated with major adverse cardiovascular events beyond the predictive capacity of conventional lipid panels .

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for cases (Rheumatoid Arthritis patients)

  • Patients fulfilling the 2010 American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria for RA
  • Disease duration of ≤6 months from the onset of symptoms (early RA)

For Controls (Healthy Subjects):

  • Healthy volunteers aged 18 to 49 years with no known inflammatory, autoimmune, or chronic disease.
  • Age- and sex-matched (within ±2 years) to case subjects

Exclusion criteria

  • Established cardiovascular disease (coronary artery disease, prior myocardial infarction, stroke, peripheral arterial disease, or heart failure).
  • Diabetes mellitus, Hypertension, and Dyslipidaemia on lipid-lowering therapy (statins, fibrates, niacin, or omega-3 agents), as these agents directly modify AIP values.
  • Chronic kidney disease (eGFR <60 mL/min/1.73 m²) and Hepatic disease, thyroid dysfunction, or any other significant endocrine disorder.
  • Pregnancy or lactation.
  • Other connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome).
  • Other inflammatory arthropathies (psoriatic arthritis, ankylosing spondylitis, reactive arthritis).

Treatment and study plan

Primary outcomes

  1. atherosclerosis assessment in early diagnosed Rheumatoid Arthritis

    Time frame: • Disease duration of ≤6 months from the onset of symptoms

    • Mean Atherogenic Index of Plasma Unitless (ratio / calculated index)
    • Mean Carotid Intima-Media Thickness measured in mm via ultrasonography

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Atherogenic Index of Plasma and Carotid Intima-media Thickness as Predictors of Preclinical Atherosclerosis in Early Rheumatoid Arthritis Patients Younger Than 50 Years of Age

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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