Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada (FHCanada)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by McGill University Health Center
Sponsor:
Collaborators:
Amgen
Sanofi
Pfizer
Merck Sharp & Dohme Corp.
Aegerion Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jacques Genest, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT02009345
First received: November 21, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients. The goal of this initiative is to create a registry of subjects with FH across Canada. Rare diseases of lipoprotein metabolism will also be included. Using a "hub and spoke" model, the registry will be extended in various communities to link primary care physicians with provincial academic centers. The registry will include clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) will be collected for biobanking. We propose a three-tier registry: local, provincial and Canada-wide, which will be completely anonymized. The registry will be made available for clinicians to manage patient care, identify relatives for screening and treatment (cascade screening), to provide advice to general practitioners and to support collaborative studies in biomedical, clinical, health outcomes and health economics research. The data extracted for the provincial portion of the database will allow administrative database research that will provide important information to key stakeholders and permit allocation of resources. It will also allow a sound and uniform rationale for the use of novel therapeutic agents and provide expert advice to regulatory agencies. At the Canadian level, the database will allow clinicians and researchers to determine the burden of disease and the long-term effects of treatment. Through the creation of a Canada-wide network of academic clinics, integrating lipid specialists, endocrinologists and cardiologists, the Canadian FH registry will lead to significant benefits for FH patients, clinicians and researchers, biopharmaceutical industry and government.


Condition
Familial Hypercholesterolemia
Lipid Disorder

Study Type: Observational [Patient Registry]
Target Follow-Up Duration: 15 Years
Official Title: Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Number of Patients with FH [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence rates of FH in Canada [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma and Buffy coat for DNA extraction DNA stock samples


Estimated Enrollment: 6000
Study Start Date: November 2013
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from primary care clinics

Criteria

Inclusion Criteria:

Diagnostic criteria for FH, which are:

  • Family and/or personal history of high cholesterol
  • Family and/or personal history of heart disease
  • Abnormal growth on tendons, accumulation of fatty material in the eye Family history of FH Severe disorder of cholesterol and other lipids in the blood

Exclusion Criteria:

No exclusion criterion

  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: NCT02009345

Contacts
Contact: Isabelle Ruel, PhD 514-934-1934 ext 34852 isabelle.ruel@mail.mcgill.ca

Locations
Canada, Quebec
Research Institute of the McGill University Health Centre: Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Isabelle Ruel, PhD    514-934-1934 ext 34258    isabelle.ruel@mail.mcgill.ca   
Principal Investigator: Jacques Genest, MD         
Sponsors and Collaborators
McGill University Health Center
Amgen
Sanofi
Pfizer
Merck Sharp & Dohme Corp.
Aegerion Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jacques Genest, MD Research Institute of the McGill University Health Centre
  More Information

No publications provided

Responsible Party: Jacques Genest, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02009345     History of Changes
Other Study ID Numbers: FH Canada
Study First Received: November 21, 2013
Last Updated: June 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Familial hypercholesterolemia,
High LDL-cholesterol
Registry
Coronary artery disease

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Hypercholesterolemia
Sphingolipidoses
Lipid Metabolism Disorders
Hyperlipidemias
Dyslipidemias
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lipidoses
Lysosomal Storage Diseases

ClinicalTrials.gov processed this record on September 18, 2014