IN-TANDEM Familial Hypercholesterolemia Pilot Study

University of Pennsylvania378 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

378

Conditions

Familial Hypercholesterolemia

Interventions

Genetic testingOTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Lancaster General Hospital

Lancaster, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Likelihood of having FH-causing mutation

Proportion of subjects with causative mutation in higher algorithm score groups

Time frame: 12 months

Data from ClinicalTrials.gov

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