Heart CT Imaging to Detect Early Coronary Artery Disease in First-Degree Relatives With High or Low Lipoprotein(a) Identified Through Family Screening

NCT06995183 | Recruiting

• 1 other identifier: 2024.1104
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Lipoprotein(a), or Lp(a), is a type of cholesterol that can increase the risk of heart and blood vessel disease. Many people are unaware they have high Lp(a), since it is not routinely measured and usually causes no symptoms on its own. However, elevated Lp(a) levels tend to run in families, meaning that close relatives of individuals with high Lp(a) are more likely to have it as well. At Amsterdam UMC, family members of patients with high Lp(a) are invited for cascade screening, which includes testing for Lp(a) and other cardiovascular risk factors. From this screened group, a selection of individuals with either high or low Lp(a) levels are invited to participate in the IMAGE-LPA study. In IMAGE-LPA, participants undergo a comprehensive cardiovascular evaluation, including blood tests and heart imaging using CT scans. Two types of scans are performed: (1) a calcium score scan to detect early calcium buildup in the heart's arteries (an early marker of atherosclerosis), and (2) coronary CT angiography to assess for plaque and narrowing in the coronary arteries. The goal of the study is to compare individuals with high versus low Lp(a) identified through cascade screening, to determine whether high Lp(a) levels are associated with early signs of heart disease in this patient group. The study does not involve any medications or invasive procedures. The findings may help clarify whether heart imaging can improve early detection in individuals with high Lp(a), and guide future strategies for preventing cardiovascular disease in families affected by this inherited risk factor.

Conditions

Lipoprotein(a)

Keywords

Lipoprotein(a); coronary atherosclerosis; subclinical atherosclerosis; coronary artery calcium scoring; coronary computed tomography angiography; cardiovascular risk assessment; primary prevention; coronary artery disease; cascade screening; imaging biomarkers; atherosclerotic cardiovascular disease; lipid disorders

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Coronary Atherosclerotic Plaque Detected on CCTA

  Assessment of the presence or absence of any coronary artery plaque as detected by coronary computed tomography angiography (CCTA). Plaque is defined as within and/or adjacent to the vessel lumen distinguishable from the lumen and surrounding tissue.

  Day 1

Secondary Outcomes (8)

• Number of Participants with Obstructive Coronary Stenosis (≥50% Luminal Narrowing) on CCTA

  Day 1

• Total Coronary Plaque Volume

  Day 1

• Calcified and Non-Calcified Plaque Volumes

  Day 1

• Low-Attenuation Plaque Volume

  Day 1

• Pericoronary Adipose Tissue (PCAT) Attenuation

  Day 1

Study Arms (2)

High Lp(a)

Individuals aged 50 years or older who were identified with elevated Lipoprotein(a) levels (≥150 nmol/L) through familial cascade screening at the Amsterdam UMC Vascular Medicine outpatient clinic. These participants have no history of clinical atherosclerotic cardiovascular disease and are undergoing imaging to assess subclinical coronary atherosclerosis.

Low Lp(a)

Age- and sex-matched individuals aged 50 years or older with normal Lipoprotein(a) levels (\<50 nmol/L), identified through the same familial cascade screening program. These participants also have no history of clinical atherosclerotic cardiovascular disease and serve as controls to compare the prevalence of subclinical coronary plaque.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from first-degree relatives of patients with elevated Lipoprotein(a) who previously participated in the Lp(a) familial cascade screening program at the Amsterdam UMC Vascular Medicine outpatient clinic. All participants have been screened for Lp(a) levels as part of routine clinical care and have indicated willingness to be contacted for future research. Eligible individuals are middle-aged or older and have no history of clinically manifest atherosclerotic cardiovascular disease.

You may qualify if:

• Man or woman ≥50 years of age;
• Lp(a) level ≥ 150 nmol/L;
• Identified as having elevated Lp(a) through Lp(a) family cascade screening at the Amsterdam UMC Vascular Medicine outpatient clinic;
• Able and willing to provide informed consent;
• Able to comply with study requirements.
• Man or woman ≥50 years of age;
• Lp(a) level \< 50 nmol/L;
• Identified as having elevated Lp(a) through Lp(a) family cascade screening at the Amsterdam UMC Vascular Medicine outpatient clinic;
• Able and willing to provide informed consent;
• Able to comply with study requirements.
• A potential subject who meets any of the following criteria will be excluded from participation in this study (both subgroups):
• Renal insufficiency, defined as eGFR \< 30 ml/min
• History of ASCVD (acute coronary syndrome, history of myocardial infarction, stable or unstable angina pectoris or coronary or other arterial revascularization, stroke, transient ischemic attack or peripheral artery disease including aortic aneurysm, all of atherosclerotic origin)
• History of atrial fibrillation
• Prior and current use of statins

Sponsors & Collaborators

• E.S.stroes: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

• Annink ME, Janssen ES, Reeskamp LF. Effectiveness of cascade screening for elevated lipoprotein(a), an underdiagnosed family disorder. Curr Opin Lipidol. 2024 Dec 1;35(6):290-296. doi: 10.1097/MOL.0000000000000951. Epub 2024 Sep 18.

  PMID: 39259684 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Maxim E Annink, MD MSc LLM

CONTACT

+31205669111; m.e.annink@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)