NCT07545408

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Childrens diagnosed with systemic lupus erythematosus

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Kerolos Atef Thabet

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04