Study of Awareness and Detection of Familial Hypercholesterolemia (CASCADE-FH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by The Familial Hypercholesterolemia Foundation
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
The Familial Hypercholesterolemia Foundation
ClinicalTrials.gov Identifier:
NCT01960244
First received: September 17, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition
Hypercholesterolemia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: CAscade SCreening for Awareness and Detection of Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by The Familial Hypercholesterolemia Foundation:

Primary Outcome Measures:
  • Promote awareness of FH to increase the number of identified FH patients, reaching optimal level of disease management; target treatment levels for LDL cholesterol. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    therapy


Estimated Enrollment: 5000
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
hypercholesterolemia
familial hypercholesterolemia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed Familial hypercholesterolemia (FH).

Criteria

Inclusion Criteria:

Online Patient Enrollment Inclusion Criteria:

  • 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.

Clinic Patient Enrollment Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960244

Locations
United States, North Carolina
Duke Clinical Research Institute Active, not recruiting
Durham, North Carolina, United States, 27705
Duke Clinical Research Institute Recruiting
Durham, North Carolina, United States, 27705
Contact: Shannon Smith-Car    919-668-8785      
Sub-Investigator: Shannon Smith-Car         
Sponsors and Collaborators
The Familial Hypercholesterolemia Foundation
Duke Clinical Research Institute
Investigators
Study Director: Katherine Wilemon FHFoundation
  More Information

Additional Information:
No publications provided

Responsible Party: The Familial Hypercholesterolemia Foundation
ClinicalTrials.gov Identifier: NCT01960244     History of Changes
Other Study ID Numbers: Pro00045568
Study First Received: September 17, 2013
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Familial Hypercholesterolemia Foundation:
familial
hypercholesterolemia
FH

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on September 29, 2014