Familial Hyperlipidemia Family Registry

Sponsor
Poudre Valley Health System (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05814419
Collaborator
(none)
104
22.8

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Familial Hyperlipidemia Family Registry
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Apr 26, 2025
    Anticipated Study Completion Date :
    Apr 26, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Primary family member of child from school screening program with documented FH variant
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Poudre Valley Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary J. Luckasen, MD, Principal Investigator, Poudre Valley Health System
    ClinicalTrials.gov Identifier:
    NCT05814419
    Other Study ID Numbers:
    • 22-1979
    First Posted:
    Apr 14, 2023
    Last Update Posted:
    Apr 14, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gary J. Luckasen, MD, Principal Investigator, Poudre Valley Health System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2023