Evaluation of Cascade Screening for Elevated Lipoprotein(a)

NCT06157983 | Active Not Recruiting

• 1 other identifier: K2023-4595
• Study Type: observational
• Target: 1,950
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Dyslipidemias; Hereditary Diseases

Keywords

Lipoprotein(a); Coronary artery disease; Cascade screening; Atherosclerotic cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  Dataset will be analysed after completion of health care development project (anticipated March 2025)

• Difference in cardiovascular risk factors between index and relatives

  Dataset will be analysed after completion of health care development project (anticipated March 2025)

Study Arms (2)

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)

Other: measurement of lipoprotein(a)

Interventions

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

Biological relative to index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska university hospital

Stockholm, Stockholm County, SE-14186, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36036785 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias; Genetic Diseases, Inborn; Coronary Artery Disease; Atherosclerosis

Interventions

Apolipoproteins A

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Apolipoproteins; Lipoproteins; Lipids; Apoproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2023
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

SE (1)