Trial Outcomes & Findings for Familial Hyperlipidemia Family Registry (NCT NCT05814419)
NCT ID: NCT05814419
Last Updated: 2025-12-19
Results Overview
Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.
Recruitment status
COMPLETED
Target enrollment
11 participants
Primary outcome timeframe
The duration of participation in study is one day.
Results posted on
2025-12-19
Participant Flow
Participant milestones
| Measure |
Observational Registry Cohort
If a child from the Healthy Hearts and Minds education and screening program is found to have a genetic marker for familial hyperlipidemia, 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.
Family members of children identified in the Health Hearts screening program were enrolled in this study; Children in the Healthy Hearts screening program were enrolled in NCT05767996
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|---|---|
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Overall Study
STARTED
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11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Familial Hyperlipidemia Family Registry
Baseline characteristics by cohort
| Measure |
Observational Registry Cohort
n=11 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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5 Participants
n=8 Participants
|
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Age, Categorical
Between 18 and 65 years
|
6 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 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.
Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.
Outcome measures
| Measure |
Observational Registry Cohort
n=11 Participants
If a child from the Healthy Hearts and Minds education and screening program is found to have a genetic marker for familial hyperlipidemia, 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.
Family members of children identified in the Health Hearts screening program were enrolled in this study; Children in the Healthy Hearts screening program were enrolled in NCT05767996
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|---|---|
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Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant
Positive
|
3 participants
|
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Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant
Negative
|
8 participants
|
Adverse Events
Adverse Events
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place