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Trial record 11 of 153 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

August 15, 2017
August 17, 2017
March 16, 2018
July 20, 2017
December 31, 2018   (Final data collection date for primary outcome measure)
Likelihood of having FH-causing mutation [ Time Frame: 12 months ]
Proportion of subjects with causative mutation in higher algorithm score groups
Same as current
Complete list of historical versions of study NCT03253432 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
IN-TANDEM Familial Hypercholesterolemia Pilot Study
INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Familial Hypercholesterolemia
Other: Genetic testing
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations
  • Strata 0-0.05
    Lowest probability of having familial hypercholesterolemia
    Intervention: Other: Genetic testing
  • Strata 0.06-0.15
    Second lowest probability of having familial hypercholesterolemia
    Intervention: Other: Genetic testing
  • Strata 0.16-0.19
    Moderate probability of having familial hypercholesterolemia
    Intervention: Other: Genetic testing
  • Strata 0.20-0.34
    Second highest probability of having familial hypercholesterolemia
    Intervention: Other: Genetic testing
  • Strata greater than or equal to 35
    Highest probability of having familial hypercholesterolemia
    Intervention: Other: Genetic testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Daniel Rader, MD 215-573-4176 rader@mail.med.upenn.edu
Contact: Amanda Baer 215-349-5023 baer2@mail.med.upenn.edu
United States
 
 
NCT03253432
826438
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other investigators
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: De-identified data will be shared at end of study after database lock
Access Criteria: Research team
University of Pennsylvania
University of Pennsylvania
  • The FH Foundation
  • Lancaster General Hospital
Not Provided
University of Pennsylvania
March 2018