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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04929457

Acronym

DigiLipids

Enrollment

30000

Registered

2021-06-18

Start date

2021-09-01

Completion date

2033-09-30

Last updated

2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia, Hypercholesterolemia

Keywords

familial hypercholesterolemia, cardiovascular disease, coronary artery disease, ischemic stroke, peripheral artery disease, hypercholesterolemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Swedish personal identification number

Exclusion criteria

* Decline informed consent

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

Sweden

Outcome results