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NCT Number: NCT04929457

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

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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Key information

Conditions

Familial Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Artery Disease Coronary Disease Dyslipidemias Genetic Diseases, Inborn Heart Diseases Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Ischemic Stroke Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska university hospital

Stockholm, SE-14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Swedish personal identification number

Exclusion criteria

  • Decline informed consent

Treatment and study plan

Primary outcomes

  1. Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia

    Time frame: 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.

  2. Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia

    Time frame: 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.

  3. Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden

    Time frame: 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.

  4. Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose

    Time frame: 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 outcomes

  1. Key efficacy numbers and ratios of screened and diagnosed for the digiphysical screening method to diagnose Familial Hypercholesterolemia

    Time frame: 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.

  2. Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: DigiLipids

Important dates

Study start
2021
Primary completion
2031
Study completion
2033
First posted
Jun 18, 2021
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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