The purpose of the research project is to investigate the potential association of 207 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score), along with the patients' response to clopidogrel and statin therapy. The aim of the study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic patient approach.
Regarding Greece, this is the first prospectively enrolling medical database of this magnitude. Clinical and genetic patient information are systematically collected in a fashion that will enable also future retrospective evaluation of clinical and genetic details from each patient. This study is a discrete arm of a series of research projects that focus on the development of personalized medical therapy and share a common purpose: predicting 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.
Study Type
OBSERVATIONAL
Enrollment
1,080
Genotyping will be carried out by Next-Generation Sequencing (NGS)
AHEPA University Hospital
Thessaloniki, Greece
RECRUITINGRelationship between genetic risk variants and the SYNTAX score
All-comers population
Time frame: 12 months
MACCEs
Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
Time frame: 12 months
Predictive value of combining a Genetic Risk Score, SYNTAX score and clinical variables for the prediction of 1-year MACCEs
A multilocus Genetic Risk Score will be calculated as the weighted sum of alleles of 207 single nucleotide polymorphisms previously associated with CAD \[The investigators will construct a multilocus genetic risk score for each individual by summing the number of risk alleles (0/1/2) for each of the 207 SNPs weighted by their estimated effect sizes\]. SYNTAX score is a coronary lesion complexity scoring system and represented by a single number. Clinical variables include: 1. Major CV risk factors as defined according to ESC Guidelines \[as dichotomous variables-yes or no\] 2. Ankle-Brachial Index: a tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis \[measurement according to ESC Guidelines-represented by a single number\] 3. Left Ventricular Ejection Fraction (LVEF%) using echocardiography.
Time frame: 12 months
Any BARC (Bleeding Academic Research Consortium) bleeding
Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition
Time frame: 12 months
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