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Subclinical Atherosclerosis in Juvenile Systemic Lupus Erythematosus

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07545408
Enrollment
70
Registered
2026-04-22
Start date
2026-06-01
Completion date
2027-08-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief summary

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).

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
CIMT values in JSLE patients compared to age- and sex-matched healthy controls.Baseline

Contacts

CONTACTKerolos Atef Thabet
keroloseatef11@gmail.com01211014182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026