NCT02009345 Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
| NCT ID | NCT02009345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Familial Hypercholesterolemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2013-11 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2013-11 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 are also included. Using a "hub and spoke" model, the registry extends in various communities to link primary care physicians with provincial academic centers. The registry includes clinical, biochemical and demographic information. Specimens (plasma/serum and DNA) are collected for biobanking. The "local" portion of the registry is available for clinicians to manage patient care, and identify relatives for screening and treatment (cascade screening). The Canada-wide registry, which is completely anonymized, will be made available 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.
Eligibility Criteria
Inclusion Criteria: * Clinical 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
Contact & Investigator
Jacques Genest, MD
PRINCIPAL INVESTIGATOR
Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT02009345 clinical trial?
This trial is open to participants of all sexes, studying Familial Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02009345 currently recruiting?
Yes, NCT02009345 is actively recruiting participants. Contact the research team at isabelle.ruel@mail.mcgill.ca for enrollment information.
Where is the NCT02009345 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT02009345 clinical trial?
NCT02009345 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Jacques Genest, MD at Research Institute of the McGill University Health Centre. The trial plans to enroll 6,000 participants.