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Trial record 11 of 152 for:    "familial hypercholesterolemia"

IN-TANDEM Familial Hypercholesterolemia Pilot Study

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ClinicalTrials.gov Identifier: NCT03253432
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
The FH Foundation
Lancaster General Hospital
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Familial Hypercholesterolemia Other: Genetic testing

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Strata 0-0.05
Lowest probability of having familial hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.06-0.15
Second lowest probability of having familial hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.16-0.19
Moderate probability of having familial hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata 0.20-0.34
Second highest probability of having familial hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations

Strata greater than or equal to 35
Highest probability of having familial hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations




Primary Outcome Measures :
  1. Likelihood of having FH-causing mutation [ Time Frame: 12 months ]
    Proportion of subjects with causative mutation in higher algorithm score groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Randomly selected patients from University of Pennsylvania and Lancaster General Hospital with at least 1 cardiovascular comorbidity seen at hospital within the past five years.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253432


Contacts
Contact: Daniel Rader, MD 215-573-4176 rader@mail.med.upenn.edu
Contact: Amanda Baer 215-349-5023 baer2@mail.med.upenn.edu

Locations
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Rolf Anderson, MD    717-544-8300    RLAnders@lghealth.org   
Contact: Heidi Testa, RN    717-544-1781    hltesta@LGHealth.org   
Principal Investigator: Rolf Anderson, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel Rader, MD    215-573-4176    rader@mail.med.upenn.edu   
Contact: Amanda Baer    215-349-5023    baer2@mail.med.upenn.edu   
Principal Investigator: Daniel Rader, MD         
Sponsors and Collaborators
University of Pennsylvania
The FH Foundation
Lancaster General Hospital

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03253432     History of Changes
Other Study ID Numbers: 826438
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other investigators
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: De-identified data will be shared at end of study after database lock
Access Criteria: Research team

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias