IN-TANDEM Familial Hypercholesterolemia Pilot Study

NCT ID: NCT03253432

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-20

Study Completion Date

2018-11-07

Brief Summary

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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

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Conditions

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Familial Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Strata 0-0.05

Lowest probability of having familial hypercholesterolemia

Genetic testing

Intervention Type OTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.06-0.15

Second lowest probability of having familial hypercholesterolemia

Genetic testing

Intervention Type OTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.16-0.19

Moderate probability of having familial hypercholesterolemia

Genetic testing

Intervention Type OTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.20-0.34

Second highest probability of having familial hypercholesterolemia

Genetic testing

Intervention Type OTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata greater than or equal to 35

Highest probability of having familial hypercholesterolemia

Genetic testing

Intervention Type OTHER

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Interventions

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Genetic testing

Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Familial Hypercholesterolemia Foundation

OTHER

Sponsor Role collaborator

Lancaster General Hospital

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Qureshi N, Da Silva MLR, Abdul-Hamid H, Weng SF, Kai J, Leonardi-Bee J. Strategies for screening for familial hypercholesterolaemia in primary care and other community settings. Cochrane Database Syst Rev. 2021 Oct 7;10(10):CD012985. doi: 10.1002/14651858.CD012985.pub2.

Reference Type DERIVED
PMID: 34617591 (View on PubMed)

Other Identifiers

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826438

Identifier Type: -

Identifier Source: org_study_id

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