Familial HypercholesterolemiaDigiLipidsNCT04929457
Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
An observational study of Familial Hypercholesterolemia and Hypercholesterolemia, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Familial Hypercholesterolemia, Hypercholesterolemia
- How many people
- 30,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to Sep 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals that partake in the Swedish national digiphysical screening program for Familial Hypercholesterolemia will be asked to give personal informed consent to participate in the longitudinal observational cohort study.
Who may be able to join
- Swedish personal identification number
Who cannot join
- Decline informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects
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.
- Keywords
- familial hypercholesterolemia, cardiovascular disease, coronary artery disease, ischemic stroke, peripheral artery disease, hypercholesterolemia
- Medical subject headings
- Hyperlipoproteinemia Type II, Hypercholesterolemia, Cardiovascular Diseases, Coronary Artery Disease, Ischemic Stroke, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals screened for Familial Hypercholesterolemia | Individuals participating in diagnostic activities in the digiphysical health care screening program for Familial Hypercholesterolemia and have provided informed consent are included in the cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, until 2041.
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.
Measured: Through study completion, until 2041.
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.
Measured: Through study completion, until 2041.
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.
Measured: Through study completion, until 2041.
Secondary outcomes (2)
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.
Measured: Through study completion, until 2041.
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.
Measured: Through study completion, until 2041.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Sep 2021
- Primary completionSep 2031 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Brinck, Karolinska Institutet
- Investigators
- Jonas Brinck, MD PhD, Principal investigator, Dept. of Medicine Huddinge H7, Karolinska Institute, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929457
- Sponsor's protocol ID
- DigiLipids
- Acronym
- DigiLipids
- Status last verified
- Mar 2023
- First submitted
- 28 May 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request data sharing is possible after discussion with responsible researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects
- ClinicalTrials.gov ID
- NCT04929457
- Acronym / sponsor ID
- DigiLipids / DigiLipids
- Keywords
- familial hypercholesterolemia, cardiovascular disease, coronary artery disease, ischemic stroke, peripheral artery disease, hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals screened for Familial Hypercholesterolemia | – | –Individuals participating in diagnostic activities in the digiphysical health care screening program for Familial Hypercholesterolemia and have provided informed consent are included in the cohort. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals that partake in the Swedish national digiphysical screening program for Familial Hypercholesterolemia will be asked to give personal informed consent to participate in the longitudinal observational cohort study.
Key inclusion criteria (1 listed)
- Swedish personal identification number
Key exclusion criteria (1 listed)
- Decline informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Yes. Upon reasonable request data sharing is possible after discussion with responsible researchers.
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An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonas Brinck, MD PhD principal investigator
Dept. of Medicine Huddinge H7, Karolinska Institute, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia and Hypercholesterolemia, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia (time frame: Through study completion, until 2041.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.