Study of Awareness and Detection of Familial Hypercholesterolemia

NCT01960244 | Unknown

• 1 other identifier: Pro00045568
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time. The registry represents a collaboration between The Familial Hypercholesterolemia Foundation, the Duke Clinical Research Institute, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes.

Conditions

Hypercholesterolemia

Keywords

familial; hypercholesterolemia; FH

Outcome Measures

Primary Outcomes (1)

• Promote awareness of FH to increase the number of identified FH patients, reaching optimal level of disease management; target treatment levels for LDL cholesterol.

  therapy

  3 Years

Study Arms (1)

hypercholesterolemia

familial hypercholesterolemia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed Familial hypercholesterolemia (FH).

You may qualify if:

• Patients with existing clinical diagnosis of FH;
• Patients with genetic mutation of FH;
• Patients with an initial (pretreatment) LDL level \>190 mg/dL or total cholesterol \>300 mg/dL;
• Patients currently taking a lipid-lowering medication and have an LDL \>124 mg/dL or total cholesterol \>195 mg/dL.
• Patients with existing clinical diagnosis of FH using one of the three clinical diagnostic (US MedPed Program Criteria, Simon Broome Register Criteria with diagnosis of "Probable", Dutch Lipid Clinic Network Diagnostic Criteria with diagnosis of "Probable")tools for FH; or
• Patients with genetic mutation of FH

You may not qualify if:

• Patients will be excluded from participation in the registry when a known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism).

Sponsors & Collaborators

• The Familial Hypercholesterolemia Foundation: lead

Study Sites (1)

Stanford Center for Inherited Cardiovascular Diseases

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (1)

• Duell PB, Gidding SS, Andersen RL, Knickelbine T, Anderson L, Gianos E, Shrader P, Kindt I, O'Brien EC, McCann D, Hemphill LC, Ahmed CD, Martin SS, Larry JA, Ahmad ZS, Kullo IJ, Underberg JA, Guyton J, Thompson P, Wilemon K, Roe MT, Rader DJ, Cuchel M, Linton MF, Shapiro MD, Moriarty PM, Knowles JW. Longitudinal low density lipoprotein cholesterol goal achievement and cardiovascular outcomes among adult patients with familial hypercholesterolemia: The CASCADE FH registry. Atherosclerosis. 2019 Oct;289:85-93. doi: 10.1016/j.atherosclerosis.2019.08.007. Epub 2019 Aug 19.

  PMID: 31487564 DERIVED

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katherine Wilemon

  FHFoundation

  STUDY DIRECTOR

Central Study Contacts

MARY CARD, MBA

CONTACT

6265834674; mcc@thefhfoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

US (1)