Vascular Health and Risk Factors in Children With Down Syndrome

Atherosclerosis Clinical Trial

Official title:

Vascular Health and Risk Factors in Children With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735874
• Other study ID #: 00127761
• Status: Completed
• Start date: February 2, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Risk Factor
• Down Syndrome
• Syndrome

Intervention

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].
• 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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Boston Children's Hospital, The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

References & Publications (61)

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.	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
Secondary	Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.	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
Secondary	Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.	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
Secondary	Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.	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
Secondary	Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.	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
Secondary	Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.	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

External Links

•   Data and Statistics on Down Syndrome - Accessed April 13, 2019
•   R Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical Computing. Published 2018.