Vascular Health and Risk Factors in Children With Down Syndrome

NCT04735874 | Completed

• 1 other identifier: 00127761
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Cardiovascular Risk Factor; Atherosclerosis

Keywords

Down Syndrome; Cardiovascular Risk Factor; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Pulse wave velocity (PWV) is a non-invasive imaging measure of arterial stiffness. Pulse wave velocity measures vascular stiffness by evaluating the time for a pressure wave to travel through the aorta. The velocity is determined by the elasticity and geometry of the vessel. PWV will be measured using a SphygmoCor device. With the participant in the supine position and ECG leads attached, the maximal pulsation of the right carotid and right femoral artery will be marked and measured from the suprasternal notch using a tape measure (carotid) and caliper (femoral). A tonometer will record the carotid and femoral impulses. The device calculates PWV as the difference in the carotid-to-distal path length divided by the difference in R-wave-to-waveform times (∆distance/∆time, m/sec). Measurements will be in triplicate and averaged. PWV can be completed in \~30 mins.

  One day patient visit

Secondary Outcomes (7)

• 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.

  One day patient visit

• Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.

  One day patient visit

• Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.

  One day patient visit

• Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.

  One day patient visit

• Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.

  One day patient visit

Study Arms (1)

Children ages 10.0 to 18.0

Other: Evaluate vascular disease risk factors in children with Down Syndrome; Other: Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome

Interventions

Evaluate vascular disease risk factors in children with Down Syndrome OTHER

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 \[lipid panel with subfractions (NMR), insulin, glucose, and CRP\].

Children ages 10.0 to 18.0

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

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.

Children ages 10.0 to 18.0

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Boston Children's Hospital: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84121, United States

Location

Related Publications (61)

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Related Links

• R Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical Computing. Published 2018.

MeSH Terms

Conditions

Down Syndrome; Atherosclerosis

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adam L Ware, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor, Pediatric Cardiology

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: February 3, 2021
• Study Start: February 2, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)