Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease

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 6 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score). The aim of the study is to combine genetic, clinical and laboratory data in order to create a prognostic tool that will enable an individualized therapeutic patient approach.

Detailed Description
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This study focus on the prediction of future risk of cardiovascular events, assessing the severity and complexity of coronary artery disease by incorporating genetic information into the SYNTAX score and providing personalized therapeutic guidance to patients. The ultimate goal of the study would be to identify, design and develop a panel of genetic markers that in combination with clinical and angiographic information will be a reliable tool for predicting cardiovascular risk for future adverse events. Clinical and genetic patient information are systematically collected in a fashion that will enable also retrospective evaluation.

Official Title
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Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease in the Greek Population

Conditions
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Coronary Artery Disease, Cardiovascular Risk Factor, Coronary Arteriosclerosis

Intervention / Treatment
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* Genetic: SNPs associated with CAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes Patients giving voluntary written consent to participate in the study Male or female patients between 18 years to 90 years at entry Patients without previous history of CAD Exclusion Criteria: Patients < 18 years old and > 90 years old at time of coronary angiography Patients with a previous history of CAD Cardiac Arrest at admission Patients with serious concurrent disease and life expectancy of < 1 year Patients who refuse to give written consent for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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) | Genetic: SNPs associated with CAD<br>* Genotyping will be carried out by Real-Time PCR<br>|
| 0 < SYNTAX score < 23<br>Low SYNTAX group | Genetic: SNPs associated with CAD<br>* Genotyping will be carried out by Real-Time PCR<br>|
| SYNTAX score ≥ 23<br>Intermediate-High SYNTAX group | Genetic: SNPs associated with CAD<br>* Genotyping will be carried out by Real-Time PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between genetic risk variants and the SYNTAX score [All-comers population] | The investigators will evaluate the effects of 6 known genetic variants associated with risk of Coronary Artery Disease on the extend and severity of coronary atherosclerosis [as assessed by the SYNTAX score] in patients with significant CAD on coronary angiography, both individually and combined in a Genetic Risk Score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCEs | Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke | 12 months | 
| Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs | A Genetic Risk Score will be calculated as the weighted sum of alleles of 6 single nucleotide polymorphisms previously associated with CAD [The GRS will be constructed by summing the number of risk alleles (0/1/2) for each of the 6 SNPs weighted by their estimated effect sizes]. SYNTAX score is a coronary lesion complexity scoring system and represented by a single number. | 12 months | 
| Ankle-Brachial Index | A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis [represented by a single number] | At hospital admission | 
| Left Ventricular Ejection Fraction | LVEF [%] as assessed by echocardiography | At hospital admission & 12 months after discharge from hospital | 
| Neutrophil to Lymphocyte Ratio | NLR [represented by a single number] | At hospital admission | 
| Red Cell Distribution Width | RDW [%] | At hospital admission | 
| Mean Platelet Volume | MPV [fL] | At hospital admission | 
| Glomerular Filtration Rate | GFR as assessed by CKD-EPI formula [mL/min/1.73m²] | At hospital admission | 
| High Density Lipoprotein | HDL [mg/dL] | At hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, SYNTAX score, Coronary Atherosclerosis, SNPs, Genetics, Genetic Risk Score, Personalized Medicine