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

April 1, 2024 updated by: Gary J. Luckasen, MD, Poudre Valley Health System
Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elementary school children participating in baseline biometric screening, including cholesterol; with those with elevated cholesterol receiving genetic testing to identify presence/absence of FH variant

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • normal cholesterol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
Time Frame: Evaluation of family members over a defined 5 year period
Percentage of school children who have elevated cholesterol related to FH variant
Evaluation of family members over a defined 5 year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poudre Valley Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-6010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Familial Hyperlipidemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe