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)

September 6, 2017 updated by: Georgios Sianos, AHEPA University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1080

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 54636
        • Recruiting
        • Ahepa University Hospital
        • Contact:
          • Georgios Sianos, MD, PhD
          • Phone Number: 0030 2310994830
          • Email: gsianos@auth.gr
        • Principal Investigator:
          • Georgios Sianos, MD,PhD,FESC
        • Principal Investigator:
          • Ioannis Vizirianakis, PharmD,PhD
        • Principal Investigator:
          • Dimitrios Chatzidimitriou, MD,PhD
        • Principal Investigator:
          • Georgios Rampidis, MD,MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between 18 years to 90 years at entry, of both genders, who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes will be studied. Patients with a previous history of coronary artery disease will be excluded. The study includes subjects who 1) have suspected CAD and undergo a scheduled diagnostic angiogram for clinical reasons, and 2) are hospitalized because of an acute coronary syndrome and thus undergo diagnostic angiography (without previous history of CAD).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SYNTAX score = 0
Patients with nonobstructive CAD (≤50 % diameter stenosis)
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data
0 < SYNTAX score <23
Low SYNTAX group
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data
SYNTAX score >= 23
Intermediate-High SYNTAX group
Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Other Names:
  • Clinical information
  • Laboratory data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between genetic risk variants and the SYNTAX score
Time Frame: 12 months
All-comers population
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCEs
Time Frame: 12 months
Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
12 months
Predictive value of combining a Genetic Risk Score, SYNTAX score and clinical variables for the prediction of 1-year MACCEs
Time Frame: 12 months

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:

  1. Major CV risk factors as defined according to ESC Guidelines [as dichotomous variables-yes or no]
  2. 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]
  3. Left Ventricular Ejection Fraction (LVEF%) using echocardiography.
12 months
Any BARC (Bleeding Academic Research Consortium) bleeding
Time Frame: 12 months
Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Collaborators

LABNET IAE - Private Reference Diagnostic Laboratory

Investigators

  • Principal Investigator: Georgios Sianos, MD PhD FESC, Ahepa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 6, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP_GESS_Trial_1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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