Vascular Health and Risk Factors in Children With Down Syndrome

NCT ID: NCT04735874

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2023-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children ages 10.0 to 18.0

Evaluate vascular disease risk factors in children with Down Syndrome

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

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

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Adam Ware

MD, Assistant Professor, Pediatric Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam L Ware, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

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Related Links

https://www.r-project.org/

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

Other Identifiers

00127761

Identifier Type: -

Identifier Source: org_study_id