Coronary Artery DiseaseGESSNCT03150680
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.
An observational study of Coronary Artery Disease, run by AHEPA University Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
- How many people
- 1,080 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2017to Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital
Thessaloniki, 54636
Georgios Sianos, MD, PhD, 0030 2310994830, gsianos@auth.gr
Georgios Sianos, MD,PhD,FESC
About this study
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.
Read the 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
- Being tested
- SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins
- Keywords
- SYNTAX score, SNPs, Genetics, Pharmacogenetics, Genetic Risk Score, Precision Medicine
- Medical subject headings
- Coronary Artery Disease, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statinsGenetic
Also called Clinical information, Laboratory data
Genotyping will be carried out by Next-Generation Sequencing (NGS)
| Study group | Role | What they receive |
|---|---|---|
| SYNTAX score = 0 | Patients with nonobstructive CAD (≤50 % diameter stenosis) Receives: Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins | |
| 0 < SYNTAX score <23 | Low SYNTAX group Receives: Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins | |
| SYNTAX score >= 23 | Intermediate-High SYNTAX group Receives: Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between genetic risk variants and the SYNTAX score
All-comers population
Measured: 12 months
Secondary outcomes (3)
MACCEs
Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
Measured: 12 months
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.
Measured: 12 months
Any BARC (Bleeding Academic Research Consortium) bleeding
Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Sep 2017
- Primary completionFeb 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LABNET IAE - Private Reference Diagnostic Laboratory
- Responsible party
- Principal investigator, Georgios Sianos, AHEPA University Hospital
- Investigators
- Georgios Sianos, MD PhD FESC, Principal investigator, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150680
- Sponsor's protocol ID
- CIP_GESS_Trial_1.1
- Acronym
- GESS
- Status last verified
- Sep 2017
- First submitted
- 9 May 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19758907Vizirianakis 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.
PubMed 16305372Vizirianakis 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.
PubMed 34103005
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03150680
- Acronym / sponsor ID
- GESS / CIP_GESS_Trial_1.1
- Conditions
- Coronary Artery Disease
- Keywords
- SYNTAX score, SNPs, Genetics, Pharmacogenetics, Genetic Risk Score, Precision Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Collaborators
- LABNET IAE - Private Reference Diagnostic Laboratory
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYNTAX score = 0 | – | Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statinsPatients with nonobstructive CAD (≤50 % diameter stenosis) |
| 0 < SYNTAX score <23 | – | Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statinsLow SYNTAX group |
| SYNTAX score >= 23 | – | Genetic: SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statinsIntermediate-High SYNTAX group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statinsAlso: Clinical information, Laboratory dataGenotyping will be carried out by Next-Generation Sequencing (NGS) | Genetic | 0 < SYNTAX score <23, SYNTAX score = 0, SYNTAX score >= 23 |
Primary outcome
Relationship between genetic risk variants and the SYNTAX score
Time frame: 12 months
All-comers population
3 secondary outcomes
MACCEs
Time frame: 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
Any BARC (Bleeding Academic Research Consortium) bleeding
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 19758907Sianos 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.
- Background: PubMed 16305372Vizirianakis 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.
- Derived from this study: PubMed 34103005Vizirianakis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Sianos, MD PhD FESC principal investigator
AHEPA University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Sianos, MD PhD FESC (0030 2310994830, gsianos@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between genetic risk variants and the SYNTAX score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150680, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.