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

E.S.stroes150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Lipoprotein(a)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

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

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

Time frame: Day 1

Total Coronary Plaque Volume

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.

Time frame: Day 1

Calcified and Non-Calcified Plaque Volumes

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.

Time frame: Day 1

Low-Attenuation Plaque Volume

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.

Time frame: Day 1

Pericoronary Adipose Tissue (PCAT) Attenuation

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.

Time frame: Day 1

Number of High-Risk Plaque Features

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.

Time frame: Day 1

Coronary Artery Calcium (CAC) Score

Agatston CAC score obtained from non-contrast CT scan preceding CCTA. Score quantifies coronary calcification. Scale: 0-400+; higher score = more calcification, worse outcome

Time frame: Day 1

CAD-RADS Classification

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%).

Time frame: Day 1

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts