跳至主要内容
临床试验/NCT07545408
NCT07545408尚未招募不适用

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

Assiut University0 个研究点目标入组 70 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
CIMT values in JSLE patients compared to age- and sex-matched healthy controls.

研究概览

简要总结

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).

详细描述

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. .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • 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
  • Patients currently receiving lipid-lowering therapy prior to enrolment

结局指标

主要结局

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

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Assiut University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerolos atef thabet mosaad

Doctor

Assiut University

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