Evaluation of Cascade Screening for Elevated Lipoprotein(a)

NCT ID: NCT06157983

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1950 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-06-16

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Index

Patient with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a).

No interventions assigned to this group

Biological relative to index

First- or second-degree relative to the index with atherosclerotic coronary artery disease and a measured plasma lipoprotein(a)

measurement of lipoprotein(a)

Intervention Type: OTHER

Plasma lipoprotein(a) will be measured in the biological relatives group as part of a clinical health care development project

Interventions

measurement of lipoprotein(a)

Plasma lipoprotein(a) will be measured in the biological relatives group as part of a clinical health care development project

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• participation in the clinical health care development project
• established atherosclerotic coronary artery disease

Exclusion Criteria

• diagnosis of familial hypercholesterolemia
• chronic kidney disease stadium ≥4

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Jonas Brinck

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska university hospital

Stockholm, Stockholm County, Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 36036785 (View on PubMed)

Other Identifiers

K2023-4595

Identifier Type: -

Identifier Source: org_study_id