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Набор скоро начнётся NCT07545408

Subclinical Atherosclerosis in Juvenile Systemic Lupus Erythematosus

Наблюдательное Atherosclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Atherosclerosis. Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

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.

Первичные конечные точки

  • CIMT values in JSLE patients compared to age- and sex-matched healthy controls. [Срок оценки: Baseline]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07545408 · atherosclerosis in SLE child

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗