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Clinical Trials/NCT03315234
NCT03315234
Unknown
Not Applicable

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

Aristotle University Of Thessaloniki1 site in 1 country270 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Aristotle University Of Thessaloniki
Enrollment
270
Locations
1
Primary Endpoint
Relationship between genetic risk variants and the SYNTAX score [All-comers population]
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgios P Rampidis, MD, MSc

Principal Investigator

Aristotle University Of Thessaloniki

Eligibility Criteria

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

Outcomes

Primary Outcomes

Relationship between genetic risk variants and the SYNTAX score [All-comers population]

Time Frame: 12 months

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

Secondary Outcomes

  • MACCEs(12 months)
  • Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs(12 months)
  • Ankle-Brachial Index(At hospital admission)
  • Left Ventricular Ejection Fraction(At hospital admission & 12 months after discharge from hospital)
  • Neutrophil to Lymphocyte Ratio(At hospital admission)
  • Red Cell Distribution Width(At hospital admission)
  • Mean Platelet Volume(At hospital admission)
  • High Density Lipoprotein(At hospital admission)
  • Glomerular Filtration Rate(At hospital admission)

Study Sites (1)

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