IN-TANDEM Familial Hypercholesterolemia Pilot Study

Completed

• Conditions: Familial Hypercholesterolemia
• Interventions: Other: Genetic testing

• Registration Number: NCT03253432
• Lead Sponsor: University of Pennsylvania

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Strata 0-0.05	Genetic testing	Lowest probability of having familial hypercholesterolemia
Strata 0.06-0.15	Genetic testing	Second lowest probability of having familial hypercholesterolemia
Strata 0.16-0.19	Genetic testing	Moderate probability of having familial hypercholesterolemia
Strata 0.20-0.34	Genetic testing	Second highest probability of having familial hypercholesterolemia
Strata greater than or equal to 35	Genetic testing	Highest probability of having familial hypercholesterolemia

Primary Outcome Measures

Name	Time	Method
Likelihood of having FH-causing mutation	12 months	Proportion of subjects with causative mutation in higher algorithm score groups

Trial Locations

Locations (2)

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States