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

NCT07772466 | Not Yet Recruiting

• 1 other identifier: atherosclerosis in early RA
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Atheroscleroses; Rheumatoid Arthritis (RA

Outcome Measures

Primary Outcomes (1)

• atherosclerosis assessment in early diagnosed Rheumatoid Arthritis

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

  • Disease duration of ≤6 months from the onset of symptoms

Study Arms (1)

early Rheumatoid arthritis patients younger than 50 years of age

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

adult patients presented to rheumatology department with early rheumatoid arthritis

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Rajabzadeh F, Akhlaghipour I, Moosavi SS, Nasimi Shad A, Babazadeh Baghan A, Shariati-Sarabi Z, Payandeh A, Hassan Nejad E. Comparison of the intima-media thickness of the common carotid artery in patients with rheumatoid arthritis: A single-center cross-sectional case-control study, and a brief review of the literature. Health Sci Rep. 2023 Nov 16;6(11):e1718. doi: 10.1002/hsr2.1718. eCollection 2023 Nov.

  PMID: 38028704 RESULT

• Xu C, Xu S, Mai P, Tang J, Xu J, Zhang H. Association between the atherogenic index of plasma and abdominal aortic calcification in adults: a cross-sectional study. BMC Public Health. 2024 Sep 6;24(1):2431. doi: 10.1186/s12889-024-19862-3.

  PMID: 39243068 RESULT

• Drosos AA, Venetsanopoulou AA, Pelechas E, Voulgari PV. Exploring Cardiovascular Risk Factors and Atherosclerosis in Rheumatoid Arthritis. Eur J Intern Med. 2024 Oct;128:1-9. doi: 10.1016/j.ejim.2024.07.016. Epub 2024 Jul 23.

  PMID: 39048336 RESULT

• Solomon DH, Demler O, Rist PM, Santacroce L, Tawakol A, Giles JT, Liao KP, Bathon JM. Biomarkers of Cardiovascular Risk in Patients With Rheumatoid Arthritis: Results From the TARGET Trial. J Am Heart Assoc. 2024 Mar 5;13(5):e032095. doi: 10.1161/JAHA.123.032095. Epub 2024 Feb 28.

  PMID: 38416140 RESULT

• Farhat H, Irfan H, Muthiah K, Pallipamu N, Taheri S, Thiagaraj SS, Shukla TS, Gutlapalli SD, Giva S, Penumetcha SS. Increased Risk of Cardiovascular Diseases in Rheumatoid Arthritis: A Systematic Review. Cureus. 2022 Dec 8;14(12):e32308. doi: 10.7759/cureus.32308. eCollection 2022 Dec.

  PMID: 36632250 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Atherosclerosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 19, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08