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

Hypercholesterolemia Clinical Trial

— DigiLipids  

Official title:

Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04929457
• Other study ID #: DigiLipids
• Status: Enrolling by invitation
• Start date: September 1, 2021
• Est. completion date: September 2033

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30000
• Est. completion date: September 2033
• Est. primary completion date: September 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Swedish personal identification number

Exclusion Criteria:

• Decline informed consent

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Locations

Country	Name	City	State
Sweden	Karolinska university hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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: 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.	Through study completion, until 2041.
Secondary	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.