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临床试验/NCT07184034
NCT07184034尚未招募不适用

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

Assiut University0 个研究点目标入组 150 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
Correlation between serum lipoprotein (a) levels and coronary artery calcium (CAC) score as measured by MSCT.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Baseline

次要结局

  • Check which of these patients will need revascularization after 6 to 12 months(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerolos Ayman Sobhy Kamel

Doctor

Assiut University

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