Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis. (GESS)

AHEPA University Hospital

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins

Study type: Observational

Funder types: Other

Identifiers

NCT03150680

CIP_GESS_Trial_1.1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,080 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients giving voluntary written consent to participate in the study
2. Male or female patients between 18 years to 90 years at entry
3. Patients without previous history of CAD
4. 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

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

Trial design

1,080 participants in 3 patient groups

SYNTAX score = 0

Description:

Patients with nonobstructive CAD (≤50 % diameter stenosis)

Treatment:

Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins

0 < SYNTAX score <23

Description:

Low SYNTAX group

Treatment:

Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins

SYNTAX score >= 23

Description:

Intermediate-High SYNTAX group

Treatment:

Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins