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.

Coronary Artery Disease Clinical Trial

— GESS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150680
• Other study ID #: CIP_GESS_Trial_1.1
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: September 6, 2017
• Start date: September 1, 2017
• Est. completion date: September 2020

Study information

• Verified date: September 2017
• Source: AHEPA University Hospital
• Contact: Georgios Sianos, MD PhD FESC
• Phone: 0030 2310994830
• Email: gsianos[@]auth.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1080
• Est. completion date: September 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Genetic:
• SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloníki

Sponsors (2)

Lead Sponsor	Collaborator
AHEPA University Hospital	LABNET IAE - Private Reference Diagnostic Laboratory

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A, Dawkins K, van den Brand M, Van Dyck N, Russell ME, Mohr FW, Serruys PW. The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease. EuroIntervention. 2005 Aug;1(2):219-27. — View Citation

Vizirianakis IS. Challenges in current drug delivery from the potential application of pharmacogenomics and personalized medicine in clinical practice. Curr Drug Deliv. 2004 Jan;1(1):73-80. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between genetic risk variants and the SYNTAX score	All-comers population	12 months
Secondary	MACCEs	Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke	12 months
Secondary	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: Major CV risk factors as defined according to ESC Guidelines [as dichotomous variables-yes or no]; 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]; Left Ventricular Ejection Fraction (LVEF%) using echocardiography.	12 months
Secondary	Any BARC (Bleeding Academic Research Consortium) bleeding	Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition	12 months