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Clinical Trials/NL-OMON47646
NL-OMON47646
Completed
Not Applicable

Cardiovascular Disease in Children with chronic inflammation - CDC study (cardiovascular disease in children)

niversitair Medisch Centrum Utrecht0 sites116 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
116
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
June 25, 2019
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

Not specified

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