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NCT Number: NCT07545408

Subclinical Atherosclerosis in Juvenile Systemic Lupus Erythematosus

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).

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Key information

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. CIMT values in JSLE patients compared to age- and sex-matched healthy controls.

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Kerolos Atef Thabet

CONTACT

[email protected]

01211014182

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 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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