Familial HypercholesterolemiaNCT03253432
IN-TANDEM Familial Hypercholesterolemia Pilot Study
An observational study of Familial Hypercholesterolemia, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Genetic testing
- How many people
- 378 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2017to 7 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Genetic testing
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testingOther
Targeted next-generation sequencing for familial hypercholesterolemia causative mutations
| Study group | Role | What they receive |
|---|---|---|
| Strata 0-0.05 | Lowest probability of having familial hypercholesterolemia Receives: Other: Genetic testing | |
| Strata 0.06-0.15 | Second lowest probability of having familial hypercholesterolemia Receives: Other: Genetic testing | |
| Strata 0.16-0.19 | Moderate probability of having familial hypercholesterolemia Receives: Other: Genetic testing | |
| Strata 0.20-0.34 | Second highest probability of having familial hypercholesterolemia Receives: Other: Genetic testing | |
| Strata greater than or equal to 35 | Highest probability of having familial hypercholesterolemia Receives: Other: Genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of having FH-causing mutation
Proportion of subjects with causative mutation in higher algorithm score groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start20 Jul 2017
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- The Familial Hypercholesterolemia Foundation, Lancaster General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253432
- Sponsor's protocol ID
- 826438
- Status last verified
- Feb 2019
- First submitted
- 15 Aug 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators
Publications
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.
PubMed 34617591
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study
- ClinicalTrials.gov ID
- NCT03253432
- Acronym / sponsor ID
- 826438
- Conditions
- Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- The Familial Hypercholesterolemia Foundation, Lancaster General Hospital
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Strata 0-0.05 | – | Other: Genetic testingLowest probability of having familial hypercholesterolemia |
| Strata 0.06-0.15 | – | Other: Genetic testingSecond lowest probability of having familial hypercholesterolemia |
| Strata 0.16-0.19 | – | Other: Genetic testingModerate probability of having familial hypercholesterolemia |
| Strata 0.20-0.34 | – | Other: Genetic testingSecond highest probability of having familial hypercholesterolemia |
| Strata greater than or equal to 35 | – | Other: Genetic testingHighest probability of having familial hypercholesterolemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic testingTargeted next-generation sequencing for familial hypercholesterolemia causative mutations | Other | Strata 0-0.05, Strata 0.06-0.15, Strata 0.16-0.19, Strata 0.20-0.34, Strata greater than or equal to 35 |
Primary outcome
Likelihood of having FH-causing mutation
Time frame: 12 months
Proportion of subjects with causative mutation in higher algorithm score groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 34617591Qureshi 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.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators
Related trials for Familial Hypercholesterolemia
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EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
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Clinical Decision Support for Familial Hypercholesterolemia
Hypercholesterolemia, Familial, Clinical Decision Support
Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood of having FH-causing mutation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.