Familial Hyperlipidemia Family Registry

Active, not recruiting

• Conditions: Familial Hyperlipidemia

• Registration Number: NCT05814419
• Lead Sponsor: Poudre Valley Health System

Brief Summary

The aim of the study is to identify children and families that are at risk for cardiovascular disease because of a condition known as familial hyperlipidemia. This condition may increase the risk of cardiac events such as hardening of the arteries anywhere in the body which can result in heart attacks, strokes, and death over ten fold.

Children have already been assessed in the Healthy Hearts screening program and identified as having elevated cholesterol. A buccal smear will identify whether the familial hyperlipidemia condition exist in your child.

If the child's test shows that they have the specific gene for familial hyperlipidemia and shows a genetic tendency towards premature heart disease, we would encourage genetic testing for as many blood family members as possible.

The study plan is to determine whether the Healthy Hearts screening program is a more effective way of identifying students at risk since it is estimated that less than 10% of those individuals with the problem have been identified. If it is effective, then it will be incorporated as part of the standard screening process in the Healthy Hearts program.

Aim 1: Is a school screening program a more effective method to identifying those at risk for familial hyperlipidemia? Aim 2: What percent of children with elevated cholesterol ≥ 200 mg/dl have familial hyperlipidemia?

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-04-26
• Study Completion: 2025-04-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

* Primary family member of child from school screening program with documented FH variant

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FH Determination for Family members of School children with elevated Cholesterol and docmented FH variant	Evaluation of family members over a defined 5 year period	Genetic evaluation for FH variants in family member of children with elevate Cholesterol on baseline screening

Trial Locations

Locations (1)

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States