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

  • STATUS
    Recruiting
  • sponsor
    The FH Foundation
Updated on 23 November 2020

Summary

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

Description

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 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 life long 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.

By participating in the CASCADE Registry, the study staff will have access to the participants’ 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 of the registry.

There is no guarantee that participants will receive direct benefit 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.

For more information, please contact:
Nelson Chen, CRC
646-317-0785
nec9039@nyp.org

Details
Clinical Study IdentifierTX150277
SponsorThe FH Foundation
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
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 total cholesterol level > 195 mg/dL
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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