NCT07772466Not yet recruiting
Atherosclerosis in Early Rheumatoid Arthritis Patients Using Atherogenic Index of the Plasma and Carotid Intima Media Thickness
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 9 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- Assiut University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07772466
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Oct 2026 to the primary completion date, 1 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Established cardiovascular disease (coronary artery disease, prior myocardial infarction, stroke, peripheral arterial disease, or heart failure).
Other illness
- Diabetes mellitus, Hypertension, and Dyslipidaemia on lipid-lowering therapy (statins, fibrates, niacin, or omega-3 agents), as these agents directly modify AIP values.
- Other connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome).
Lab values
- Chronic kidney disease (eGFR \<60 mL/min/1.73 m²) and Hepatic disease, thyroid dysfunction, or any other significant endocrine disorder.
Other
- Pregnancy or lactation.
- Other inflammatory arthropathies (psoriatic arthritis, ankylosing spondylitis, reactive arthritis).
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.