IN-TANDEM Familial Hypercholesterolemia Pilot Study

University of Pennsylvania

Status: Completed

Conditions: Familial Hypercholesterolemia

Treatments: Other: Genetic testing

Study type: Observational

Funder types: Other

Identifiers

NCT03253432

826438

Details and patient eligibility

About

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

Enrollment: 378 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

378 participants in 5 patient groups

Strata 0-0.05

Description:

Lowest probability of having familial hypercholesterolemia

Treatment:

Other: Genetic testing

Strata 0.06-0.15

Description:

Second lowest probability of having familial hypercholesterolemia

Treatment:

Other: Genetic testing

Strata 0.16-0.19

Description:

Moderate probability of having familial hypercholesterolemia

Treatment:

Other: Genetic testing

Strata 0.20-0.34

Description:

Second highest probability of having familial hypercholesterolemia

Treatment:

Other: Genetic testing

Strata greater than or equal to 35

Description:

Highest probability of having familial hypercholesterolemia

Treatment:

Other: Genetic testing