IN-TANDEM Familial Hypercholesterolemia Pilot Study

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

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Key information

Conditions

Familial Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lancaster General Hospital, Lancaster, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic Testing

Other

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Primary outcomes

Likelihood of having FH-causing mutation

Time frame: 12 months

Proportion of subjects with causative mutation in higher algorithm score groups

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

Lancaster General Hospital
The Familial Hypercholesterolemia Foundation

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 17, 2017
Registry last updated: Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed