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
1 other identifier
observational
1,080
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 7, 2017
September 1, 2017
2.4 years
May 9, 2017
September 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relationship between genetic risk variants and the SYNTAX score
All-comers population
12 months
Secondary Outcomes (3)
MACCEs
12 months
Predictive value of combining a Genetic Risk Score, SYNTAX score and clinical variables for the prediction of 1-year MACCEs
12 months
Any BARC (Bleeding Academic Research Consortium) bleeding
12 months
Study Arms (3)
SYNTAX score = 0
Patients with nonobstructive CAD (≤50 % diameter stenosis)
0 < SYNTAX score <23
Low SYNTAX group
SYNTAX score >= 23
Intermediate-High SYNTAX group
Interventions
Genotyping will be carried out by Next-Generation Sequencing (NGS)
Eligibility Criteria
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).
You may qualify if:
- 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
- Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AHEPA University Hospital
Thessaloniki, 54636, Greece
Related Publications (3)
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.
PMID: 19758907BACKGROUNDVizirianakis 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.
PMID: 16305372BACKGROUNDVizirianakis 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.
PMID: 34103005DERIVED
Biospecimen
DNA will be extracted from obtained subject blood samples at the AHEPA University General Hospital of Thessaloniki. DNAs will be labeled by anonymized subject ID # (de-identified), and shipped to LABNET IAE - Private Reference Diagnostic Laboratory for genotyping and genetic analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Sianos, MD PhD FESC
AHEPA University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Cardiology MD, PhD, FESC
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 12, 2017
Study Start
September 1, 2017
Primary Completion
February 1, 2020
Study Completion
September 1, 2020
Last Updated
September 7, 2017
Record last verified: 2017-09