Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia

• Conditions: Familial Hypercholesterolemia; Hypercholesterolemia

• Registration Number: NCT04929457
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-18
• Study Start: 2021-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2031-09
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• Swedish personal identification number

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Exclusion Criteria

• Decline informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden	Through study completion, until 2041.	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.
Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose	Through study completion, until 2041.	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.
Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia	Through study completion, until 2041.	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.
Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia	Through study completion, until 2041.	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.

Secondary Outcome Measures

Name	Time	Method
Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia	Through study completion, until 2041.	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.
Key efficacy numbers and ratios of screened and diagnosed for the digiphysical screening method to diagnose Familial Hypercholesterolemia	Through study completion, until 2041.	The efficacy of the digiphysical screening method will be assessed by key numbers and ratios: * screened; * biochemically tested with cholesterol measurement; * genetically tested; * diagnosed with Familial Hypercholesterolemia; * biochemically tested/screened; * genetically tested/screened; * diagnosed with Familial Hypercholesterolemia/screened; Data is reported after 2, 5, 10, 15 and 20 years.

Trial Locations

Locations (1)

Karolinska university hospital; 🇸🇪 Stockholm, Sweden