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Familial Hyperlipidemia Family Registry

Familial Hyperlipidemia Family Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05814419
Enrollment
11
Registered
2023-04-14
Start date
2023-02-17
Completion date
2025-05-29
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hyperlipidemia

Keywords

Cholesterol, School based, Biometric Screening, Genetic, Healthy Hearts, Children

Brief summary

If a child from the Healthy Hearts and Minds education and screening program is found to have a genetic marker for familial hyperlipidemia (FH), immediate family members are offered genetic testing at no charge to identify those at high risk for cardiovascular disorders and those who carry the genetic markers. If identified early, the risk for cardiovascular disease can be greatly modified by early and proper treatment. The aim of the study is to gauge the impact of large-scale surveillance testing to identify those with the disorder and improve clinical care. This impact is both in disease prevention and in lessening the cost of long-term care from premature cardiovascular disease.

Interventions

None listed

Sponsors

Poudre Valley Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 60 Years
Healthy volunteers
No

Inclusion criteria

\* Primary family member of child from school screening program with documented familial hyperlipidemia (FH) variant

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH VariantThe duration of participation in study is one day.Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.

Countries

United States

Participant flow

Participants by arm

ArmCount
Observational Registry Cohort
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.
11
Total11

Baseline characteristics

CharacteristicObservational Registry Cohort
Age, Categorical
<=18 years
5 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
11 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 11
other
Total, other adverse events
0 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant

Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.

Time frame: The duration of participation in study is one day.

Population: Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.~Not enough subjects participating to allow statistical analysis.

ArmMeasureGroupValue (NUMBER)
Observational Registry CohortFamilial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH VariantPositive3 participants
Observational Registry CohortFamilial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH VariantNegative8 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026