Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile

Study Overview
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Brief Summary
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The purpose of the research project is to investigate the potential association of the complexity and the severity of coronary artery disease (as assessed via SYNTAX score) with patients' metabolic profile. The aim of the study is to combine biochemical, clinical and laboratory data in order to create an algorithm that will enable an individualized therapeutic patient approach.

Detailed Description
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The objective of this observational study is to expand our knowledge on the biochemical process and pathogenesis of atherogenesis and to recognize clinically important metabolic biomarkers correlated with the severity and clinical presentation of Coronary Artery Disease (CAD). 1050 patients who will undergo coronary angiography will be enrolled in the study. SYNTAX score will be calculated for all participants and their blood samples will be collected before coronary angiography. Metabolomics-based analysis will be performed in order to confirm CAD prognostic biomarkers previously reported in the literature and to investigate their correlations with CAD clinical data. The ultimate aim of this study is to predict the risk of cardiovascular events by incorporating metabolomic information into the SYNTAX score and provide personalized therapeutic guidance to patients.

Official Title
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Correlation of Clinical Types and Complexity of Coronary Artery Disease With Patients' Metabolic Profile

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: metabolomics analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients giving voluntary written consent to participate in the study Adults Patients without previous history of coronary artery disease Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes Exclusion Criteria: Cardiac Arrest at admission Patients with serious concurrent disease and life expectancy of < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SYNTAX score = 0<br>Patients with nonobstructive CAD (≤50 % diameter stenosis) | Diagnostic Test: metabolomics analysis<br>* Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.<br>|
| 0 < SYNTAX score <=22<br>Low SYNTAX group | Diagnostic Test: metabolomics analysis<br>* Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.<br>|
| 23<=SYNTAX score<=32<br>Intermediate SYNTAX group | Diagnostic Test: metabolomics analysis<br>* Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.<br>|
| SYNTAX score>=33<br>High SYNTAX group | Diagnostic Test: metabolomics analysis<br>* Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between metabolic profile and the SYNTAX score | Serum metabolomic biomarkers (ceramides, acyl-carnitines, total fatty acids and protein markers: Galectin-3, Neutrophil Gelatinase-Associated Lipocalin, Adiponectin, ApolipoproteinB/ ApolipoproteinΑ-Ι) will be quantified using metabolomics-based methods and enzyme-linked immunosorbent assay. The SYNTAX score will be calculated for all patients. Correlation between patients' metabolic profile and the SYNTAX score will be performed. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of serum ceramide species | Quantification of serum ceramide species (C18:0/16:0, C18:0/18:0, C18:0/24:0 and C18:0/24:1) using a developed Ultra-high performance liquid chromatography tandem mass spectrometry method. | 12 months | 
| Concentration of serum acyl-carnitines | Quantification of serum acyl-carnitines (C2, C3, C4, isoC4, C5, isoC5, C6, C8, C10, C12, C14, C16, C18, C18:1 C18:2) using a developed hydrophilic interaction chromatography tandem mass spectrometry method. | 12 months | 
| Concentration of serum total fatty acids | Quantification of total fatty acids (C10:0, C12:0, C14:0, C15:0, C16:0, C16:1, C17:0, C18:0, C18:1 cis, C18:2 cis, C20:0, C18:3 n6, C18:3 n3, C20:1, C20:2, C22:0, C20:3 n6, C22:1 & C20:4, C23:0, C20:5, C24:0, C24:1, C22:6) using a developed gas chromatography with flame-ionization method. | 12 months | 
| Concentration of serum selective protein markers | Quantification of selective protein markers (Galectictin-3, NGAL, Adiponectin, ApoB/ ApoΑ-Ι) | 12 months | 
| Major Adverse Cardiovascular and Cerebrovascular Events | Cardiovascular death, myocardial infarction, stent thrombosis, revascularization and stroke | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, metabolomics