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Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia. The information collected in the screening process will be combined in pseudo-anonymous form with data from the National Board of Health and Welfare (registries: Cause of Death, Diagnoses according to International Classification of Diseases (ICD) and Prescribed drugs) and Statistic Sweden (Longitudinal integrated database for health insurance and labour market studies). Primary analysis: association between Familial Hypercholesterolemia and cardiovascular disease. Secondary analysis: efficacy and health economic aspects of digiphysical screening for Familial Hypercholesterolemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals screened for Familial Hypercholesterolemia | Individuals participating in diagnostic activities in the digiphysical health care screening program for Familial Hypercholesterolemia and have provided informed consent are included in the cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia | Presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease in relation to age in patients with newly diagnosed Familial Hypercholesterolemia. Data is reported after 2, 5, 10, 15 and 20 years. | Through study completion, until 2041. |
| Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia | Change in presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease in relation to age in patients diagnosed Familial Hypercholesterolemia. Comparison is done between baseline and after 2, 5, 10, 15 and 20 years. | Through study completion, until 2041. |
| Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden | Comparison of cardiovascular disease burden (presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease) in relation to age in patients with mutation positive versus negative Familial Hypercholesterolemia. Data is reported after 2, 5, 10, 15 and 20 years. | Through study completion, until 2041. |
| Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose | Comparison of cardiovascular disease burden (presence of ischemic heart disease, ischemic cerebrovascular disease and/or peripheral artery disease) in relation to age between patients diagnosed with Familial Hypercholesterolemia and individuals screened but acquitted of the diagnose. Data is reported after 2, 5, 10, 15 and 20 years. | Through study completion, until 2041. |
| Measure | Description | Time Frame |
|---|---|---|
| Key efficacy numbers and ratios of screened and diagnosed for the digiphysical screening method to diagnose Familial Hypercholesterolemia | The efficacy of the digiphysical screening method will be assessed by key numbers and ratios:
Data is reported after 2, 5, 10, 15 and 20 years. |
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Inclusion Criteria:
Exclusion Criteria:
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All individuals that partake in the Swedish national digiphysical screening program for Familial Hypercholesterolemia will be asked to give personal informed consent to participate in the longitudinal observational cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Jonas Brinck, MD PhD | Dept. of Medicine Huddinge H7, Karolinska Institute, Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska university hospital | Stockholm | SE-14186 | Sweden |
Upon reasonable request data sharing is possible after discussion with responsible researchers.
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First result anticipated two years after start.
Ethical committee approval Purpose to publish results in peer-reviewed international scientific journal
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D000083242 | Ischemic Stroke |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Through study completion, until 2041. |
| Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia | Costs and cost-benefits for digiphysical screening and treatment of individuals diagnosed with Familial Hypercholesterolemia. Data is reported after 2, 5, 10, 15 and 20 years. | Through study completion, until 2041. |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |