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.

NCT ID: NCT03150680

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1080 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-09-30

Brief 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.

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SYNTAX score = 0

Patients with nonobstructive CAD (≤50 % diameter stenosis)

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

Intervention Type: GENETIC

Genotyping will be carried out by Next-Generation Sequencing (NGS)

0 < SYNTAX score <23

Low SYNTAX group

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

Intervention Type: GENETIC

Genotyping will be carried out by Next-Generation Sequencing (NGS)

SYNTAX score >= 23

Intermediate-High SYNTAX group

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

Intervention Type: GENETIC

Genotyping will be carried out by Next-Generation Sequencing (NGS)

Interventions

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

Genotyping will be carried out by Next-Generation Sequencing (NGS)

Intervention Type: GENETIC

Other Intervention Names

Clinical information; Laboratory data

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LABNET IAE - Private Reference Diagnostic Laboratory

UNKNOWN

Sponsor Role: collaborator

AHEPA University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georgios Sianos

Associate Professor of Cardiology MD, PhD, FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Sianos, MD PhD FESC

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital

Locations

AHEPA University Hospital

Thessaloniki, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Georgios Sianos, MD PhD FESC

Role: CONTACT

gsianos@auth.gr

0030 2310994830

Facility Contacts

Georgios Sianos, MD, PhD

Role: primary

gsianos@auth.gr

0030 2310994830

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 19758907 (View on PubMed)

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. doi: 10.2174/1567201043480009.

Reference Type: BACKGROUND

PMID: 16305372 (View on PubMed)

Vizirianakis IS, Chatzopoulou F, Papazoglou AS, Karagiannidis E, Sofidis G, Stalikas N, Stefopoulos C, Kyritsis KA, Mittas N, Theodoroula NF, Lampri A, Mezarli E, Kartas A, Chatzidimitriou D, Papa-Konidari A, Angelis E, Karvounis Eta, Sianos G. The GEnetic Syntax Score: a genetic risk assessment implementation tool grading the complexity of coronary artery disease-rationale and design of the GESS study. BMC Cardiovasc Disord. 2021 Jun 8;21(1):284. doi: 10.1186/s12872-021-02092-5.

Reference Type: DERIVED

PMID: 34103005 (View on PubMed)

Other Identifiers

CIP_GESS_Trial_1.1

Identifier Type: -

Identifier Source: org_study_id