Clinical trial NCT04735874: Vascular Health and Risk Factors in Children With Down Syndrome
Official title: Vascular Health and Risk Factors in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Cardiovascular Risk Factor
Atherosclerosis
Keywords: Down Syndrome
Cardiovascular Risk Factor
Atherosclerosis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: The Hospital for Sick Children
First posted: 2021-02-03
Enrollment: 55
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children with DS (10.0-18.0 years of age) will be eligible, including those with translocations and mosaicism

Brief summary: This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* All children with Down Syndrome (10.0-18.0 years of age)
* Children with translocations and mosaicism
* Children with and without CHD

Exclusion Criteria:

* Patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions
* Patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study
* Participants whose parent/legally authorized representative (LAR) perceives the child is not able to cooperate with vascular imaging studies

Primary outcomes:
measure: The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point.
timeFrame: One day patient visit
Secondary outcomes:
measure: The difference in mean carotid intimal medial thickness between children with Down syndrome and published national data in children without Down syndrome measured at 1 time point.
timeFrame: One day patient visit
measure: Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
measure: Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
measure: Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
measure: Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
measure: Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
measure: Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
timeFrame: One day patient visit
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Adam L Ware, MD
role: PRINCIPAL_INVESTIGATOR
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