Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LABNET IAE - Private Reference Diagnostic Laboratory | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNTAX score = 0 | Patients with nonobstructive CAD (≤50 % diameter stenosis) |
| |
| 0 < SYNTAX score <23 | Low SYNTAX group |
| |
| SYNTAX score >= 23 | Intermediate-High SYNTAX group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins | Genetic | Genotyping will be carried out by Next-Generation Sequencing (NGS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between genetic risk variants and the SYNTAX score | All-comers population | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACCEs | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Sianos, MD PhD FESC | Contact | 0030 2310994830 | gsianos@auth.gr |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Sianos, MD PhD FESC | AHEPA University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Recruiting | Thessaloniki | 54636 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19758907 | Background | 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. | |
| 16305372 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
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:
| 12 months |
| Any BARC (Bleeding Academic Research Consortium) bleeding | Bleeding Academic Research Consortium (BARC) recently proposed a novel standardized bleeding definition | 12 months |
| 34103005 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000096442 | Genetic Risk Score |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided