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

Aristotle University Of Thessaloniki270 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Coronary Artery Disease Cardiovascular Risk Factor Coronary Arteriosclerosis

Interventions

SNPs associated with CADGENETIC

Genotyping will be carried out by Real-Time PCR

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes 2. Patients giving voluntary written consent to participate in the study 3. Male or female patients between 18 years to 90 years at entry 4. Patients without previous history of CAD Exclusion Criteria: 1. Patients \< 18 years old and \> 90 years old at time of coronary angiography 2. Patients with a previous history of CAD 3. Cardiac Arrest at admission 4. Patients with serious concurrent disease and life expectancy of \< 1 year 5. Patients who refuse to give written consent for participation in the study

Locations (1)

AHEPA University Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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 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.

Time frame: 12 months

Ankle-Brachial Index

A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis \[represented by a single number\]

Time frame: At hospital admission

Left Ventricular Ejection Fraction

LVEF \[%\] as assessed by echocardiography

Time frame: At hospital admission & 12 months after discharge from hospital

Neutrophil to Lymphocyte Ratio

NLR \[represented by a single number\]

Time frame: At hospital admission

Data from ClinicalTrials.gov

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