Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Familial Hypercholesterolemia, Hypercholesterolemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects
Overview
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.
Primary outcome measures
- Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia [Time frame: Through study completion, until 2041.]
- Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia [Time frame: Through study completion, until 2041.]
- Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden [Time frame: Through study completion, until 2041.]
- Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose [Time frame: Through study completion, until 2041.]
Secondary outcome measures (2)
- 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.]
- Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia [Time frame: Through study completion, until 2041.]
Eligibility criteria
Inclusion criteria
- Swedish personal identification number
Exclusion criteria
- Decline informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Karolinska university hospital — Stockholm
Identifiers
NCT: NCT04929457 · DigiLipids