Vascular Health and Risk Factors in Children With Down Syndrome

August 8, 2023 updated by: Adam Ware, University of Utah
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children ages 10.0 to 18.0
Other: Evaluate vascular disease risk factors in children with Down Syndrome
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].
Other: Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: One day patient visit
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: One day patient visit
Carotid intimal medial thickness (CIMT) is a non-invasive imaging measure of carotid artery thickness. B-mode ultrasound with a high-resolution linear array vascular transducer will be used to record common, bulb, and internal CIMT.
One day patient visit
Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
Height (centimeters) will be measured using standard stadiometers and weight (kilograms) using a calibrated scale available at each site. BMI (kg/m2) will be calculated and converted to age- and sex-matched Down Syndrome percentiles. Measured at 1 time point.
One day patient visit
Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
Waist circumference will be measured at the top of the posterior iliac crest (NHANES standard) and normalized by calculating waist to height ratio. Measured at 1 time point.
One day patient visit
Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
A fasting lipid profile will be obtained to measure total cholesterol, triglycerides, and HDL cholesterol. Trained pediatric phlebotomists will perform the blood draw after the participant has fasted ≥10 hours. A standard lipid profile will provide total cholesterol, HDL cholesterol, and triglycerides. LDL will be calculated using the Friedwald equation when triglycerides are <400 mg/dL. For triglycerides ≥400 mg/dl, LDL will be measured directly via a homogeneous enzymatic assay. Measured at 1 time point.
One day patient visit
Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
Lipoprotein subfractions by NMR will be used to describe lipid particle number and size. These lipoprotein measurements likely estimate CV risk more accurately than a standard lipid profile alone. Lipoprotein sub-fractionation will be completed using proton NMR signals. Measured at 1 time point.
One day patient visit
Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
Insulin resistance will be assessed by fasting serum glucose, hemoglobin A1C, and insulin level since diabetes (fasting glucose ≥126 mg/dL or hemoglobin A1C ≥6.5%) is a major risk factor. Measured at 1 time point.
One day patient visit
Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time Frame: One day patient visit
A detailed personal history for congenital heart disease (CHD) and associated surgery, sleep apnea, hypothyroidism, and cancer will be obtained as all are common in the population with Down Syndrome and increase the risk for cardiovascular disease in adulthood. The fundamental CHD and associated surgery will be obtained from the medical records. The parent/LAR will be questioned and the medical record reviewed for a history of sleep apnea, hypothyroidism, and cancer (yes/no). Measured at 1 time point.
One day patient visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

The Hospital for Sick Children
Boston Children's Hospital

Investigators

  • Principal Investigator: Adam L Ware, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00127761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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