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School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia

Sponsor
Poudre Valley Health System (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05767996
Collaborator
(none)
104
Enrollment
1
Location
14.9
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia [Evaluation of family members over a defined 5 year period]

      Percentage of school children who have elevated cholesterol related to FH variant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant

    Exclusion Criteria:
    • normal cholesterol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center of the Rockies Loveland Colorado United States 80538

    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, University of Colorado Health
    ClinicalTrials.gov Identifier:
    NCT05767996
    Other Study ID Numbers:
    • 20-6010
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperlipoproteinemia Type II
    Hyperlipidemias
    Hyperlipoproteinemias

    Study Results

    No Results Posted as of Mar 14, 2023