Cardiovascular Disease in Children with chronic inflammatio

Completed

• Conditions: Atherosclerosis; coronary disease; 10011082; 10003816; 10003018

• Registration Number: NL-OMON47646
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-25
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 116

Inclusion Criteria

General criteria for all groups:
* 12-19 years of age ;Obese adolescents:
Definition according to the international standards of the International Obesity Task Force, see Cole et al, BMJ, 2000. ;JIA adolescents:
* Polyarticular course JIA, including polyarticular JIA and extended oligoarticular JIA, rheumafactor negatieve. These patients often suffer from lifelong rheumatic disease, and are therefore at risk for early atherosclerosis.
* More than 1 year after diagnosis. In first year of disease, patients undergo multiple study procedures, causing a burden on patients. In order to reduce the general burden, this study will focus on patients after their first year of disease.
* BMI-SD < 2 (no obese children). ;Corrected aortic arch anomalies adolescents:
* Corrected aortic arch anomalies, i.e. hypoplastic aortic arch, coarctatio aortae, interrupted aortic arch. These patients are at risk for hypertension and early atherosclerosis.
* BMI-SD (standard deviation from BMI corrected for age and sex) < 2, to prevent including obese children in this group, to prevent obesity being a confounder in later analysis. ;Cystic fibrosis adolescents:
- Established cystic fibrosis, all mutations.
- BMI-SD < 2, to prevent inclusion of obese children so that obesity cannot be a confounder in later analysis. ;Corrected ASD adolescents:
* Corrected ASD.
* No other cardiac anomalies.
* BMI-SD < 2, to prevent inclusion of obese children so that obesity cannot be a confounder in later analysis.
NB. ASD correction < age 1 year has an excellent prognosis and is not associated with enhanced risk of early atherosclerosis.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Intoxication (smoking, drug-use)
* Acute illness (fever)
* Mental retardation
* Claustrophobia
* A history of allergic reactions to MR contrast fluids
* Implanted electronic devices (i.e. pacemaker, internal cardioverter-defibrillator, cochlear implants, nerve- and bone stimulators)
* Subjects with ferromagnetic clips in brain, eyes or lungs
* A known reduced kidney function (GFR< 60 ml/min/1.73m2)
* Pregnancy
* Subjects who do not wish to be informed about abnormal findings of the cardiovascular MRI

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>iNKT cell numbers and function: numbers will be quantified by flow cytometry,<br /><br>function will be quantified by in vitro stimulation with iNKT cell ligands<br /><br>followed by quantitative PCR of iNKT cell cytokines.<br /><br>Early atherosclerosis: measured by cardiovascular magnetic resonance imaging<br /><br>(MRI), using aortic wall thickness and volume as the main readout. </p><br>