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NCT Number: NCT07184034

Lipoprotein a Assessment and Relation to Ca Score in CAD Patients Using MSCT

The goal of this observational study is to evaluate whether serum Lipoprotein(a) [Lp(a)] levels are associated with coronary artery calcium (CAC) score measured by multi-slice computed tomography (MSCT) in adults undergoing cardiac risk assessment.

The main questions it aims to answer are:

* Is there a correlation between elevated Lp(a) levels and higher CAC scores? * Does Lp(a) provide additional predictive value for subclinical atherosclerosis beyond traditional cardiovascular risk factors?

Participants will:

* Undergo a non-contrast MSCT scan to measure CAC score. * Provide a blood sample for measurement of Lp(a) and routine lipid profile. * Have baseline clinical and demographic data collected, including cardiovascular risk factors.

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Key information

About this study

Lipoprotein(a) [Lp(a)] is a genetically determined lipoprotein particle structurally similar to LDL, with an additional apolipoprotein(a) component. Elevated Lp(a) levels have been identified as an independent and causal risk factor for atherosclerotic cardiovascular disease (ASCVD). The pro-atherogenic, pro-thrombotic, and pro-inflammatory properties of Lp(a) contribute to plaque development and vascular calcification.

Coronary artery calcium (CAC) score, assessed by non-contrast multi-slice computed tomography (MSCT), is a widely validated imaging biomarker of subclinical coronary atherosclerosis. CAC burden strongly predicts future cardiovascular events and is frequently used for individualized risk stratification. Recent studies suggest that individuals with elevated Lp(a) may also demonstrate higher CAC scores and faster progression of coronary calcification. However, the strength and consistency of this association remain insufficiently defined across different populations.

This observational study is designed to evaluate the correlation between serum Lp(a) levels and CAC score in adult participants undergoing cardiovascular risk assessment. Participants will undergo non-contrast MSCT scanning for CAC scoring, fasting blood sampling for Lp(a) and routine lipid profile, and collection of baseline demographic and clinical risk factors. Multivariable analyses will assess the independent relationship between Lp(a) and CAC score, as well as the potential incremental predictive value of Lp(a) beyond traditional risk factors such as LDL-C, hypertension, diabetes, and smoking.

We hypothesize that higher Lp(a) levels will be associated with higher CAC scores, independent of conventional cardiovascular risk factors, and that patients with both elevated Lp(a) and high CAC (≥100) will represent the subgroup at greatest risk for ASCVD. Demonstrating this relationship may improve cardiovascular risk stratification and highlight the importance of integrating Lp(a) measurement with imaging-based assessment in the early prevention of ASCVD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1-adults aged 40-70
  • 2- classified as intermediate cardiovascular risk (10-20% 10 years ASCVD risk)
  • 3-undergoing MsCT for suspected coronary artery disease
  • 4- ability to provide informed consent

Exclusion criteria

  • 1- known CAD or prior revascularization
  • 2-history of myocardial infarction or stroke
  • 3- statin or PCK9 inhibitor use in the past 3 months
  • 4-renal insufficiency (eGFR < 45ml/min/1.73m2)
  • 5-active inflammation or autoimmune disease

Treatment and study plan

Primary outcomes

  1. Correlation between serum lipoprotein (a) levels and coronary artery calcium (CAC) score as measured by MSCT.

    Time frame: Baseline

Secondary outcomes

  1. Check which of these patients will need revascularization after 6 to 12 months

    Time frame: Baseline

Study contacts

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

Kerolos Kamel

CONTACT

[email protected]

+201282111275

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of the Correlation Between Lipoprotein (a) Levels and Coronary Artery Findings on Multislice Computed Tomography

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 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.

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