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

E.S.stroes

Status: Enrolling

Conditions: Lipoprotein(a)

Study type: Observational

Funder types: Other

Identifiers

NCT06995183

2024.1104

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

150 participants in 2 patient groups

High Lp(a)

Description:

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)

Description:

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.