Lipoprotein(a)IMAGE-LPANCT06995183
Heart CT Imaging to Detect Early Coronary Artery Disease in First-Degree Relatives With High or Low Lipoprotein(a) Identified Through Family Screening
An observational study of Lipoprotein(a), run by E.S.stroes at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lipoprotein(a)
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2025to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
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.
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Maxim E Annink, MD MSc LLM, +31205669111, m.e.annink@amsterdamumc.nl
About this study
Official title: Improved Assessment of Cardiovascular Risk Through Imaging in Relatives Identified By Lipoprotein(a) Cascade 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.
Read more
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
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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%).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startJun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipoprotein(a)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E.S.stroes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995183
- Sponsor's protocol ID
- 2024.1104
- Acronym
- IMAGE-LPA
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because participants did not provide explicit consent for their data to be shared beyond the scope of the approved study. Data sharing was not included as part of the informed consent process.
Publications
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.
PubMed 39259684