NCT05767996

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

March 2, 2023

Last Update Submit

April 1, 2024

Conditions

Familial Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

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

    Evaluation of family members over a defined 5 year period

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • normal cholesterol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 14, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations

US(1)