- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109368
The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
Study Overview
Status
Conditions
Detailed Description
Detailed information of "standard of care" procedures will be compiled in a database. These include medical history and physical exam, lipid profiles and other standard blood tests, dietary evaluation and counseling, cardiology evaluation including EKG and echocardiogram,ultrasound of carotids and femoral arteries, CT angiogram and, if indicated, intracoronary angiography (ICA) with intravascular ultrasound (IVUS) and stress echo or nuclear stress testing.
The recommendation for treatment will be individualized. Current options are a) FDA approved cholesterol-lowering medications: statins, ezetimibe b) LDL-apheresis c) liver transplant d) portacaval shunt e) investigational drugs. Treatment of vascular and/or valvular disease may include aspirin, beta blockers, clopidogrel, angioplasty with metal stent, coronary artery bypass surgery, aortic valve repair/replacement.
Research procedures will include medical photos of skin xanthomas, blood assays (apolipoproteins A and B, LDL particle size, homocysteine, TNF, IL-6, insulin, glucose, ICAM, VCAM, P and E selectin, and endothelial progenitor cells), and DNA analysis of the genes for the LDL receptor and other lipid-related genes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lisa C. Hudgins, M.D.
- Phone Number: 646-317-0805
- Email: lih2013@nyp.org
Study Locations
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-
New York
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New York, New York, United States, 10021
- Recruiting
- The Rogosin Institute, Weill Cornell Medical College
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Contact:
- Lisa C. Hudgins, M.D.
- Phone Number: 646-317-0805
- Email: lih2013@nyp.org
-
Principal Investigator:
- Lisa Hudgins, M.D.
-
Sub-Investigator:
- Bruce Gordon, M.D.
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Sub-Investigator:
- Theodore Tyberg, M.D.
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Sub-Investigator:
- Daniel Levine, Ph.D.
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Sub-Investigator:
- Thomas Parker, Ph.D.
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Sub-Investigator:
- Geoffrey Bergman, M.D.
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Sub-Investigator:
- Sheila Carroll, M.D.
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Sub-Investigator:
- Ajay Mirani, M.D.
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Sub-Investigator:
- Akiko Maehera, M.D.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
1. Patients of any age and sex who meet clinical or genetic criteria for hoFH as follows:
Documented, untreated fasting LDL cholesterol level of > 500 mg/dL and triglycerides < 200 mg/dL on a cholesterol-lowering diet for at least 8 weeks with secondary causes excluded, AND:
- DNA confirmation of a double mutation of the LDL receptor or apoB gene OR
- LDL > 160 mg/dL in both biological parents not associated with a disorder know to elevate LDL OR
- Coronary artery disease in one or both parents or grandparents < 55 years for males, < 65 for females OR
- Tendinous/cutaneous xanthomas < age 10 or coronary artery disease < age 20
Exclusion criteria:
1. Inability of patient, or, if less than 18, a parent, to sign informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in disease progression
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa C. Hudgins, M.D., The Rogosin Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0912010770
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Homozygous Familial Hypercholesterolemia
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Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
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Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
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REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
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Institut Investigacio Sanitaria Pere VirgiliRecruitingFamilial Hypercholesterolemia | Familial Hypercholesterolemia - Homozygous | Familial Hypercholesterolemia - HeterozygousSpain
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Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
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Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
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First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingHomozygous Familial HypercholesterolemiaChina
-
Beijing Suncadia Pharmaceuticals Co., LtdNot yet recruitingHomozygous Familial Hypercholesterolemia
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Arrowhead PharmaceuticalsActive, not recruitingHomozygous Familial HypercholesterolemiaAustralia, Canada, United States, South Africa
-
AkesoAD Pharmaceuticals Co., Ltd.CompletedHomozygous Familial HypercholesterolemiaChina