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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Correlation between serum lipoprotein (a) levels and coronary artery calcium (CAC) score as measured by MSCT. [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Check which of these patients will need revascularization after 6 to 12 months [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zeitouni M, Nanna MG, Sun JL, Chiswell K, Peterson ED, Navar AM. Performance of Guideline Recommendations for Prevention of Myocardial Infarction in Young Adults. J Am Coll Cardiol. 2020 Aug 11;76(6):653-664. doi: 10.1016/j.jacc.2020.06.030. PMID 32762899
• Kobayashi R, Kawakatsu S, Morioka D, Suzuki A. Diversity of dopamine transporter images in frontotemporal lobar degeneration-motor neuron disease. Psychogeriatrics. 2022 Sep;22(5):771. doi: 10.1111/psyg.12860. Epub 2022 Jun 5. No abstract available. PMID 35665572
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• Kamstrup PR, Benn M, Tybjaerg-Hansen A, Nordestgaard BG. Extreme lipoprotein(a) levels and risk of myocardial infarction in the general population: the Copenhagen City Heart Study. Circulation. 2008 Jan 15;117(2):176-84. doi: 10.1161/CIRCULATIONAHA.107.715698. Epub 2007 Dec 17. PMID 18086931
• Tsimikas S. A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies. J Am Coll Cardiol. 2017 Feb 14;69(6):692-711. doi: 10.1016/j.jacc.2016.11.042. PMID 28183512
• Budoff MJ, Shaw LJ, Liu ST, Weinstein SR, Mosler TP, Tseng PH, Flores FR, Callister TQ, Raggi P, Berman DS. Long-term prognosis associated with coronary calcification: observations from a registry of 25,253 patients. J Am Coll Cardiol. 2007 May 8;49(18):1860-70. doi: 10.1016/j.jacc.2006.10.079. Epub 2007 Apr 20. PMID 17481445
• Greenland P, Blaha MJ, Budoff MJ, Erbel R, Watson KE. Coronary Calcium Score and Cardiovascular Risk. J Am Coll Cardiol. 2018 Jul 24;72(4):434-447. doi: 10.1016/j.jacc.2018.05.027. PMID 30025580

Идентификаторы

NCT: NCT07184034 · Lipoprotein a assessment

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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