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Familial Hypercholesterolemia

Protocol Title

CASCADE FH Registry: Cascade Screening for Awareness and Detection of Familial Hypercholesterolemia

Principal Investigator

Lisa Hudgins, MD
Office Number: (646) 317-0805

Study Status

Open for Enrollment

Brief Summary of the Protocol

The purpose of this registry is to collect and maintain clinical information about patients that have been diagnosed with Familial Hypercholesterolemia (FH).  The information will be used to look at the current treatment, events, and outcomes of these patients.  This will help further the understanding of the disease and improve care, quality of life, and survival of patients with FH.

FH is a common genetic condition that occurs in approximately 1 in 300-500 individuals.  FH is characterized by a dramatically high level of LDL-C, which is not related to diet or lifestyle. Because of a lifelong burden of high cholesterol levels, young individuals with FH have a greater risk of coronary disease compared to the general population.  FH is genetically inherited, and if one person is diagnosed with FH, his/her family members should also be screened.

Potential candidates are males or females, with an existing clinical diagnosis of FH, which is generally characterized by a pre-treatment (no lipid-lowering medication) LDL-C level >190 mg/dL, or total cholesterol level >300 mg/dL.  Potential candidates that are receiving treatment (on lipid-lowering medication) with a diagnosis of FH are generally characterized by having an LDL-C level >124 mg/dL or a total cholesterol level > 195 mg/dL.  By participating in the CASCADE Registry, the study staff will have access to the participant’s medical records.  The study staff will collect information such as the medical history, procedures, laboratory results, and current medications from the participants’ medical records. There is no limit on the length of time participants will be in the study; participants will be in the registry as long as it remains open, or the participant decides to stop taking part in the registry.

Potential Benefits

There is no guarantee that participants will receive direct benefits from this study.  However, participation in this study may help others get a better treatment for their FH in the future, and allow researchers to learn more about the management of FH, and promote awareness for FH.

IRB Information

Western IRB
IRB #20122110

Sponsor Information

The FH Foundation NCT01960244
Identifier: NCT01960244

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