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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorE.S.stroes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: High Lp(a)
Group B: Low Lp(a)

Trial outcomes

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.

Time frame
Day 1

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

E.S.stroes

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution