IN-TANDEM Familial Hypercholesterolemia Pilot Study

Familial Hypercholesterolemia Clinical Trial

Official title:

INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253432
• Other study ID #: 826438
• Status: Completed
• Start date: July 20, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national initiative that utilizes machine learning and data mining techniques to identify individuals whose profiles are consistent with FH patients. The algorithm will be tested in adults with at least one cardiovascular comorbidity. Study subjects will be asked to provide either a saliva, buccal or venous blood sample for DNA and biomarker analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• At least one cardiovascular co-morbidity or receiving treatment for a cardiovascular comorbidity

• Algorithm score 0-1

• Most recent encounter with a provider within five years of query date

Exclusion Criteria:

• Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound study data

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Other:
• Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Locations

Country	Name	City	State
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Lancaster General Hospital, The FH Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likelihood of having FH-causing mutation	Proportion of subjects with causative mutation in higher algorithm score groups	12 months