Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06995183

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lipoprotein(a) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Maxim E Annink, MD MSc LLM

CONTACT

[email protected]

+31205669111

Who can participate

Only the study team can determine whether someone qualifies for participation.

In order to be eligible to participate in this study in the elevated Lp(a) subgroup, a subject must meet all of the following inclusion criteria:

  • 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.

In order to be eligible to participate in this study in the Low Lp(a) subgroup, a subject must meet all of the following inclusion criteria:

  • 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
  • Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
  • Unable or unwilling to provide informed consent
  • Unable to comply with study requirements.

Treatment and study plan

Primary outcomes

  1. Number of Participants with Coronary Atherosclerotic Plaque Detected on CCTA

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: Day 1

    Measured by CCTA. Obstructive stenosis is defined as luminal narrowing of ≥50% in any major coronary artery, based on visual assessment and automated quantification.

  2. Total Coronary Plaque Volume

    Time frame: Day 1

    Total plaque volume (in mm³) across all coronary segments, quantified using FDA-approved software (Cleerly Inc.) from CCTA scans. Includes both calcified and non-calcified plaque.

  3. Calcified and Non-Calcified Plaque Volumes

    Time frame: Day 1

    Volumes (in mm³) of calcified and non-calcified coronary plaque separately measured using semi-automated quantification of CCTA images. Non-calcified plaque includes fibrous and lipid-rich components.

  4. Low-Attenuation Plaque Volume

    Time frame: Day 1

    Volume (in mm³) of coronary plaque with CT attenuation <30 HU, measured on CCTA. Low-attenuation plaque is associated with high-risk morphology and vulnerability.

  5. Pericoronary Adipose Tissue (PCAT) Attenuation

    Time frame: Day 1

    Mean CT attenuation (in Hounsfield Units) of adipose tissue surrounding coronary arteries, as a surrogate of coronary inflammation. Measured on CCTA at the proximal right coronary artery.

  6. Number of High-Risk Plaque Features

    Time frame: Day 1

    CCTA-based count of high-risk plaque features per patient, including positive remodeling, napkin-ring sign, low-attenuation plaque, and spotty calcification. A higher count suggests greater risk of future events.

  7. Coronary Artery Calcium (CAC) Score

    Time frame: Day 1

    Agatston CAC score obtained from non-contrast CT scan preceding CCTA. Score quantifies coronary calcification.

    Scale: 0-400+; higher score = more calcification, worse outcome

  8. CAD-RADS Classification

    Time frame: Day 1

    Coronary Artery Disease Reporting and Data System (CAD-RADS) score, a standardized grading system for coronary stenosis severity based on CCTA. Scores range from 0 (no plaque) to 5 (severe stenosis ≥70%).

Study contacts

Contact information is provided by the study sponsor or research team.

Maxim E Annink, MD MSc LLM

CONTACT

[email protected]

+31205669111

Sponsors and collaborators

Lead sponsor

E.S.stroes

Other

Registry information

Official study title

Improved Assessment of Cardiovascular Risk Through Imaging in Relatives Identified By Lipoprotein(a) Cascade Screening

Acronym: IMAGE-LPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.