The aim of the FH Canada registry is to improve the detection and management of individuals and families with FH in Canada. The project will identify those affected by FH with the aim of lowering their high blood cholesterol and thus preventing early cardiovascular disease such as heart attack and stroke. Patients with other severe lipid disorder will also be included.
Purpose of the FH Canada initiative
Individuals with FH have a very high risk of developing early cardiovascular diseases. Early treatment is useful to prevent early heart disease in people with FH. The purpose of the project is to identify and help get treatment started for people who are unaware that they have FH or are not being treated properly. In Canada, the burden of disease is estimated to be approximately 83,500 patients. Our goal is to create a list of individuals (a registry) with the diagnosis of FH in Canada. This will greatly simplify education and treatment of these people in the future.
Strategy of the study
We use the method of “cascade screening”, which involves testing of lipid levels in all primary (parents, siblings, and children), secondary (aunts, uncles, grandparents, grandchildren) and third-degree (cousins, nephews, nieces) relatives of the family member diagnosed with FH. This method has been used in other countries with a great deal of success and it has been established that this process of “seek and treat” saves both lives and money through this health promotion/disease prevention strategy. The data collected includes personal data, contact information for you and your family physician, medical and familial history, lifestyle data, and laboratory findings. This data will be used only for the purpose of monitoring your treatment and your health. Only the study doctor will have access to this data, it will be kept confidential. The personal data will not be shared with other study doctors or linked with other databases. With your permission, some of the data included in the database will be entered in a province-wide database. You will not be identified except by your health insurance identifier. This will allow each province to determine the number of FH cases in the province and to determine health outcomes, resource utilization and health economics, essential information in order to provide better healthcare. A third database, the Canadian FH Registry, will include information of Canadians with FH. In the Canadian database, which will serve for Canada-wide statistics on FH, no identifier (name, ID number, date of birth, address) will be included.
Who can participate?
You may participate in this study if you have a:
- 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.
What are the possible benefits to participating?
- Early diagnosis of FH, particularly of family members who may not yet know they have FH (cascade screening).
- Expert care and better management of high cholesterol levels resulting in the prevention of heart disease in patients with FH.
- Support and information for individuals with FH.
- New information obtained from the registry will be used to guide and inform research studies directed at improving our knowledge and treatment of FH, which may benefit patients with FH or other persons with elevated blood lipids in the future.
- One of the goals of the registry is to develop comparative statistics on the patients in the registry so that patients can see how they are doing in relation to other FH patients. We hope that this will encourage patients to become involved in their own health care.
- Access to on-going trials and to novel therapies (new drugs).
What does the study involve?
You will be asked about your family history for high cholesterol and your personal medical history related to diseases of heart or blood vessel and use of medications (this first visit should take about 30-45 minutes). If you are already on lipid-lowering medications, we will ask you for information about your pre-treatment and on-treatment cholesterol levels and provide you with information on achieving proper cholesterol levels using Canadian guidelines for the diagnosis and treatment of high cholesterol. If you have never been tested, we will give you a requisition to get your blood drawn and then we will follow up with you when we get the results. We will be testing your cholesterol and sugar levels in the fasted state (no food or drinks, except water, for 12 hours before the test). The lab will take about 15 ml (1.5 tablespoons) of blood. With your approval, a sample of blood plasma and DNA will be kept at the participating lipid clinic. If you have been tested and are uncertain if you do or do not have FH, we will discuss the test results with you or -with your approval- with your family physician. With your approval, your family physician will be notified of your participation in the study so that your study doctor and your family doctor can provide proper medical care. All your study data will be available to you and, if you wish, also sent to your family physician. With your approval, you will be followed up every year about your management. You will be interviewed about your health, current treatment and laboratory findings. This can be done by phone interview or if you wish, by personal visit. There are no costs to you for taking part in the FH Canada registry, and you will not be paid for taking part either.
You can participate in the FH Canada registry if you are a patient with FH or a family member of a patient diagnosed with FH, or because you present a severe disorder of cholesterol and other lipids in the blood. Your participation is voluntary. You have the right to refuse to participate in this study. If you decide to participate, you may still choose to withdraw from the study at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving. All information collected about you during your participation in the study will be kept for analysis. Before you decide, it is important for you to understand what the research involves. The consent form will tell you about the study, why the research is being done, what will happen to you during the study and the possible benefits, risks and discomforts. You also need to know that there are important differences between being in a research study and being cared for by your doctor. When you participate in a research study, the main goal is to learn things to help other patients in the future. Outside a research study, your doctor’s only goal is to care for your health. Nevertheless, the researchers have a duty of care to all subjects and will inform you of any information that may affect your willingness to remain in the study. If you wish to participate in this study, you will be asked to sign the consent form. Please take time to read it carefully and to discuss it with your family, friends, and doctor before you decide.
Your confidentiality will be respected according to the Canadian Personal Information Protection and Electronic Documents Act (PIPEDA S.C.2000c.5). No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law. You will be assigned a unique study number as a subject in this study. Only this number will be used on any research related information collected about you during the course of this study, so that your identity [i.e. your name or any other information that could identify you] as a subject in this study will be kept confidential. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to insure that your privacy is respected and also give you the right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. If you choose to enter the study and decide to withdraw, which you may do at any time, all data collected about you during your enrollment in the study will be retained for analysis but will be kept anonymous. To withdraw from this study, simply notify the study coordinator (listed on your signed consent form) in writing.
How to participate?
1-Make sure you meet the requirements to participate to this study (see “Who can participate?” section above)
2-Check the list of FH Canada participating clinics in the “Get involved” section to find one near you and contact their study coordinator for an appointment. Download a copy of the approved Institutional consent form to read prior to your appointment, if available.
3-Talk to your general practitioner or family doctor about your involvement in the FH Canada Registry, he or she may want to access the “Health Care Professionals” section for details and/or become a FH Canada participating clinician.