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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04929457
Other study ID # DigiLipids
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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