Cardiovascular DiseasesLipoaScreenNCT06157983
Evaluation of Cascade Screening for Elevated Lipoprotein(a)
An observational study of Cardiovascular Diseases and Dyslipidemias, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Dyslipidemias, Hereditary Diseases
- What is being tested?
- measurement of lipoprotein(a)
- How many people
- 1,950 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 16 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are participating in the clinical health care development project performed at six Swedish hospitals are eligible. Index group consists of patients with atherosclerotic coronary artery disease and a plasma lipoprotein(a) measured in the clinical routine. The index invite, according to the health care development project, their first- and second-degree relatives to participate in cascade screening to have their plasma lipoprotein(a) measured . Index group, n=750 (n=250 for each lipoprotein(a) strata low, intermediate, high) Relatives group, n=1200 (n=200 for first degree relatives and n=200 for second degree relatives for each of the index lipoprotein(a) strata)
Who may be able to join
- participation in the clinical health care development project
- established atherosclerotic coronary artery disease
Who cannot join
- diagnosis of familial hypercholesterolemia
- chronic kidney disease stadium ≥4
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska university hospital
Stockholm, Stockholm County, SE-14186
About this study
Official title: Evaluation of Cascade Screening for Elevated Lipoprotein(a) in Relatives to Patients With Atherosclerotic Coronary Artery Disease
The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project.
Read the detailed description
An elevated plasma level of lipoprotein(a) [Lp(a)] is an independent and causative risk factor for atherosclerotic cardiovascular disease. The Lp(a) plasma level is predominantly genetically determined via a complex hereditary pattern of the LPA gene, and remains relatively constant throughout an individual's entire life cycle. The relationship between plasma Lp(a) and the risk for a cardiovascular event has been shown to be linear.
Cascade screening, i.e. screening of biological relatives of the first detected patient (index) with a disease in a family, is an effective approach to identify and diagnose new patients with hereditary diseases. The method has been shown to be cost-effective for the most common genetically caused dyslipidemia, familial hypercholesterolemia, but the knowledge if cascade screening would be an effective method to screen for elevated plasma Lp(a) is not known.
The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives. The study will be based on results from a clinical health care development project in which patients who have had their plasma Lp(a) measured in the clinical routine will be asked to participate in the project. The participating patients invite their relatives to participate in the cascade screening and to measure their plasma Lp(a) levels. Six Swedish hospitals participate in the project and 750 patients with atherosclerotic coronary artery disease be included and divided into three strata according to their plasma Lp(a) level (low <70 nmol/L; intermediate 70-169 nmol/L; high >170 nmol/L). The indexes will in turn invite 1200 first- and second-degree relatives to have their plasma Lp(a) measured.
A scientific evaluation of the health care development project will be performed to study the penetrance of elevated plasma Lp(a) levels in indexes to their relatives.
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Hereditary Diseases
- Being tested
- measurement of lipoprotein(a)
- Keywords
- Lipoprotein(a), Coronary artery disease, Cascade screening, Atherosclerotic cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias, Genetic Diseases, Inborn, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of lipoprotein(a)Other
Plasma lipoprotein(a) will be measured in the biological relatives group as part of a clinical health care development project
| Study group | Role | What they receive |
|---|---|---|
| Index | Patient with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a). | |
| Biological relative to index | First- or second-degree relative to the index with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a) Receives: Other: measurement of lipoprotein(a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of elevated plasma lipoprotein(a) between index and first degree relatives
Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between first degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)
Measured: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Difference in proportion of elevated plasma lipoprotein(a) between index and second degree relatives
Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between second degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)
Measured: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Secondary outcomes (2)
Difference in cardiovascular disease burden between index and relatives
Difference in prevalence of cardiovascular disease manifestations (coronary artery disease, ischemic stroke, peripheral artery disease) between index and relatives in each of the Lp(a) strata of the index (low, intermediate and high).
Data on index will be recorded by a health care professional and data on relatives will be self-reported.
Measured: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Difference in cardiovascular risk factors between index and relatives
Difference in prevalence of cardiovascular risk factors (hypertension, diabetes, smoking status) between index and relatives in each of the Lp(a) strata of the index (low, intermediate and high).
Data on index will be recorded by a health care professional and data on relatives will be self-reported.
Measured: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Dec 2023
- Primary completion16 Jun 2025 (estimated)
- Study completion16 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Brinck, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157983
- Sponsor's protocol ID
- K2023-4595
- Acronym
- LipoaScreen
- Status last verified
- Jun 2025
- First submitted
- 23 Nov 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the General Data Protection Regulation (GDPR) only data on aggregated level will be made available
Publications
Kronenberg F, Mora S, Stroes ESG, Ference BA, Arsenault BJ, Berglund L, Dweck MR, Koschinsky M, Lambert G, Mach F, McNeal CJ, Moriarty PM, Natarajan P, Nordestgaard BG, Parhofer KG, Virani SS, von Eckardstein A, Watts GF, Stock JK, Ray KK, Tokgozoglu LS, Catapano AL. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J. 2022 Oct 14;43(39):3925-3946. doi: 10.1093/eurheartj/ehac361.
PubMed 36036785
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cascade Screening for Elevated Lipoprotein(a) in Relatives to Patients With Atherosclerotic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06157983
- Acronym / sponsor ID
- LipoaScreen / K2023-4595
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Hereditary Diseases
- Keywords
- Lipoprotein(a), Coronary artery disease, Cascade screening, Atherosclerotic cardiovascular disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 6 Dec 2023 (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.
The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives based on data from a clinical health care development project.
Detailed description
An elevated plasma level of lipoprotein(a) [Lp(a)] is an independent and causative risk factor for atherosclerotic cardiovascular disease. The Lp(a) plasma level is predominantly genetically determined via a complex hereditary pattern of the LPA gene, and remains relatively constant throughout an individual's entire life cycle. The relationship between plasma Lp(a) and the risk for a cardiovascular event has been shown to be linear.
Cascade screening, i.e. screening of biological relatives of the first detected patient (index) with a disease in a family, is an effective approach to identify and diagnose new patients with hereditary diseases. The method has been shown to be cost-effective for the most common genetically caused dyslipidemia, familial hypercholesterolemia, but the knowledge if cascade screening would be an effective method to screen for elevated plasma Lp(a) is not known.
The aim of the current project is to evaluate the penetrance of elevated plasma Lp(a) levels in patients with atherosclerotic coronary artery disease to their first- and second-degree biological relatives. The study will be based on results from a clinical health care development project in which patients who have had their plasma Lp(a) measured in the clinical routine will be asked to participate in the project. The participating patients invite their relatives to participate in the cascade screening and to measure their plasma Lp(a) levels. Six Swedish hospitals participate in the project and 750 patients with atherosclerotic coronary artery disease be included and divided into three strata according to their plasma Lp(a) level (low <70 nmol/L; intermediate 70-169 nmol/L; high >170 nmol/L). The indexes will in turn invite 1200 first- and second-degree relatives to have their plasma Lp(a) measured.
A scientific evaluation of the health care development project will be performed to study the penetrance of elevated plasma Lp(a) levels in indexes to their relatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index | – | –Patient with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a). |
| Biological relative to index | – | Other: measurement of lipoprotein(a)First- or second-degree relative to the index with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are participating in the clinical health care development project performed at six Swedish hospitals are eligible. Index group consists of patients with atherosclerotic coronary artery disease and a plasma lipoprotein(a) measured in the clinical routine. The index invite, according to the health care development project, their first- and second-degree relatives to participate in cascade screening to have their plasma lipoprotein(a) measured . Index group, n=750 (n=250 for each lipoprotein(a) strata low, intermediate, high) Relatives group, n=1200 (n=200 for first degree relatives and n=200 for second degree relatives for each of the index lipoprotein(a) strata)
Key inclusion criteria (2 listed)
- participation in the clinical health care development project
- established atherosclerotic coronary artery disease
Key exclusion criteria (2 listed)
- diagnosis of familial hypercholesterolemia
- chronic kidney disease stadium ≥4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of lipoprotein(a)Plasma lipoprotein(a) will be measured in the biological relatives group as part of a clinical health care development project | Other | Biological relative to index |
Primary outcome
Difference in proportion of elevated plasma lipoprotein(a) between index and first degree relatives
Time frame: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between first degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)
Difference in proportion of elevated plasma lipoprotein(a) between index and second degree relatives
Time frame: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Difference in proportion of low, intermediate and high plasma lipoprotein(a) levels between second degree relatives stratified on index patients Lp(a) level (i.e low, intermediate, high)
2 secondary outcomes
Difference in cardiovascular disease burden between index and relatives
Time frame: Dataset will be analysed after completion of health care development project (anticipated March 2025)
Difference in cardiovascular risk factors between index and relatives
Time frame: Dataset will be analysed after completion of health care development project (anticipated March 2025)
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 8 Jun 2025.
- Background: PubMed 36036785Kronenberg F, Mora S, Stroes ESG, Ference BA, Arsenault BJ, Berglund L, Dweck MR, Koschinsky M, Lambert G, Mach F, McNeal CJ, Moriarty PM, Natarajan P, Nordestgaard BG, Parhofer KG, Virani SS, von Eckardstein A, Watts GF, Stock JK, Ray KK, Tokgozoglu LS, Catapano AL. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement. Eur Heart J. 2022 Oct 14;43(39):3925-3946. doi: 10.1093/eurheartj/ehac361.
- Individual participant dataSharing planned: Undecided. Due to the General Data Protection Regulation (GDPR) only data on aggregated level will be made available
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Diseases and Dyslipidemias, 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. 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?
Difference in proportion of elevated plasma lipoprotein(a) between index and first degree relatives (time frame: Dataset will be analysed after completion of health care development project (anticipated March 2025)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157983, which also lists 1 linked publication.
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 8 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.