CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Evaluate vascular disease risk factors in children with Down Syndrome +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04735874
NCT04735874N/ACompleted

Vascular Health and Risk Factors in Children With Down Syndrome

University of Utah·observational·Posted Feb 3, 2021·Updated Aug 14, 2023

In Brief

An observational study evaluating Evaluate vascular disease risk factors in children with Down Syndrome and Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome for Down Syndrome and 2 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 3, 2021
Enrollment StartFeb 2, 2021
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.4 years ago

Interventions

Evaluate vascular disease risk factors in children with Down Syndromeother

We will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw \[lipid panel with subfractions (NMR), insulin, glucose, and CRP\].

Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndromeother

We will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children.