Subclinical Atherosclerosis in Juvenile Systemic Lupus Erythematosus

April 16, 2026 updated by: Kerolos atef thabet mosaad, Assiut University

Subclinical Atherosclerosis in Juvenile Systemic Lupus Erythematosus: Evaluation by Carotid Intima-Media Thickness and Associated Cardiovascular Risk Factors

The aim of this study is to evaluate subclinical atherosclerosis in children and adolescents with juvenile SLE by measuring carotid intima-media thickness (CIMT), and to determine its associations with traditional cardiovascular risk factors (dyslipidemia, hypertension, obesity) and non-traditional disease-related risk factors (disease activity, lupus nephritis, corticosteroid dose, disease duration).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Juvenile systemic lupus erythematosus (JSLE) is a chronic multisystem autoimmune disease affecting individuals under 18 years of age, with reported incidence rates of 0.3-0.9 per 100,000 children per year and a prevalence ranging from 3.3 to 24 per 100,000 children globally . Approximately 10-20% of all SLE cases are diagnosed during childhood, and the disease typically follows a more severe clinical course in children than in adults .

Cardiovascular disease (CVD) has emerged as the leading cause of morbidity and mortality in SLE, with patients facing a 2-10 times higher risk of developing CVD compared to the general population, and an up to 50-fold increased risk in young women of reproductive age .

In children with JSLE, CVD-related mortality is significantly elevated compared to age-matched healthy peers, and subclinical atherosclerosis has been reported in up to 32% of pediatric SLE patients (4).

This process is driven by a complex interplay of traditional risk factors - including dyslipidemia, hypertension, and obesity - alongside non-traditional disease-related factors such as persistent disease activity, lupus nephritis, prolonged corticosteroid use, and immune dysregulation (5).

Carotid intima-media thickness (CIMT) measured by B-mode ultrasonography is a validated, non-invasive surrogate marker for early atherosclerosis. Meta-analyses of SLE populations have demonstrated significantly increased CIMT and higher prevalence of carotid plaques in SLE patients compared to healthy controls . In JSLE specifically the Atherosclerosis Prevention in Pediatric Lupus Erythematosus, CIMT was established as the primary measure for tracking atherosclerosis progression. .

However, the associations between specific cardiovascular risk factors and CIMT in pediatric lupus cohorts in our region remain poorly characterized, highlighting the need for this prospective evaluation.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Childrens diagnosed with systemic lupus erythematosus

Description

Inclusion Criteria:

- Children and adolescents aged under 18 years diagnosed with JSLE according to the Systemic Lupus International Collaborating Clinics ( SLICC 2012 Criteria ).

Disease duration of at least 6 months.

Under regular follow-up at the study institution.

Exclusion Criteria:

  • Patients with other autoimmune or connective tissue overlap diseases (e.g., mixed connective tissue disease, juvenile dermatomyositis).

Patients with congenital heart disease or known structural cardiovascular abnormalities.

Patients with chronic kidney disease stage 4 or 5.

Patients currently receiving lipid-lowering therapy prior to enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CIMT values in JSLE patients compared to age- and sex-matched healthy controls.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • atherosclerosis in SLE child

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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