By InvitationNot Applicable

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

Sweden30,000 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Swedish personal identification number Exclusion Criteria: * Decline informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia

Timeframe: Through study completion, until 2041.

Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia

Timeframe: Through study completion, until 2041.

Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden

Timeframe: Through study completion, until 2041.

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

Timeframe: Through study completion, until 2041.

Trial details

NCT IDNCT04929457

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-09

View on ClinicalTrials.gov More Familial Hypercholesterolemia trials

Plain-language summary

What they're measuring

Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia

Timeframe: Through study completion, until 2041.

Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia

Timeframe: Through study completion, until 2041.

Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden

Timeframe: Through study completion, until 2041.

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

Timeframe: Through study completion, until 2041.