CClinicalTrials.gg
Not yet recruitingNCT07772466Updated Aug 19, 2026

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

An observational study in Atheroscleroses and Rheumatoid Arthritis (RA, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 50 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Atheroscleroses
  • Rheumatoid Arthritis (RA
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult patients presented to rheumatology department with early rheumatoid arthritis

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

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).
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • early Rheumatoid arthritis patients younger than 50 years of age
05

What researchers measure

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

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 38028704 ↗
  • 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. PubMed 39243068 ↗
  • 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. PubMed 39048336 ↗
  • 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. PubMed 38416140 ↗
  • 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. PubMed 36632250 ↗

Related links

08

Registry details

Key details

Study ID
NCT07772466
Lead sponsor
Assiut University
Responsible party
Shenouda Heshmat Abdou (resident, Assiut University) — Principal investigator
First posted
Aug 19, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
May 1, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Aug 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion