Not provided
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 6 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score). The aim of the study is to combine genetic, clinical and laboratory data in order to create a prognostic tool that will enable an individualized therapeutic patient approach.
This study focus on the prediction of 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. Clinical and genetic patient information are systematically collected in a fashion that will enable also retrospective evaluation.
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 | Genetic | Genotyping will be carried out by Real-Time PCR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between genetic risk variants and the SYNTAX score [All-comers population] | The investigators will evaluate the effects of 6 known genetic variants associated with risk of Coronary Artery Disease on the extend and severity of coronary atherosclerosis [as assessed by the SYNTAX score] in patients with significant CAD on coronary angiography, both individually and combined in a Genetic Risk Score | 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 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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Georgios Rampidis, MD, MSc | AHEPA University Hospital, 1st Cardiology Department - PhD candidate | Principal Investigator |
| Georgios Sianos, MD, PhD, FESC | AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1 | Principal Investigator |
| Charalambos Karvounis, MD, PhD | AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2 | Principal Investigator |
| Ioannis Vizirianakis, PharmD, PhD | Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | 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. | |
| 28856136 | Background | Knowles JW, Zarafshar S, Pavlovic A, Goldstein BA, Tsai S, Li J, McConnell MV, Absher D, Ashley EA, Kiernan M, Ioannidis JPA, Assimes TL. Impact of a Genetic Risk Score for Coronary Artery Disease on Reducing Cardiovascular Risk: A Pilot Randomized Controlled Study. Front Cardiovasc Med. 2017 Aug 14;4:53. doi: 10.3389/fcvm.2017.00053. eCollection 2017. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| NCT03150680 | Clinical Study Report | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000096442 | Genetic Risk Score |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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 Genetic Risk Score will be calculated as the weighted sum of alleles of 6 single nucleotide polymorphisms previously associated with CAD [The GRS will be constructed by summing the number of risk alleles (0/1/2) for each of the 6 SNPs weighted by their estimated effect sizes].
SYNTAX score is a coronary lesion complexity scoring system and represented by a single number.
| 12 months |
| Ankle-Brachial Index | A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis [represented by a single number] | At hospital admission |
| Left Ventricular Ejection Fraction | LVEF [%] as assessed by echocardiography | At hospital admission & 12 months after discharge from hospital |
| Neutrophil to Lymphocyte Ratio | NLR [represented by a single number] | At hospital admission |
| Red Cell Distribution Width | RDW [%] | At hospital admission |
| Mean Platelet Volume | MPV [fL] | At hospital admission |
| Glomerular Filtration Rate | GFR as assessed by CKD-EPI formula [mL/min/1.73m²] | At hospital admission |
| High Density Lipoprotein | HDL [mg/dL] | At hospital admission |
| 28530674 | Background | Howson JMM, Zhao W, Barnes DR, Ho WK, Young R, Paul DS, Waite LL, Freitag DF, Fauman EB, Salfati EL, Sun BB, Eicher JD, Johnson AD, Sheu WHH, Nielsen SF, Lin WY, Surendran P, Malarstig A, Wilk JB, Tybjaerg-Hansen A, Rasmussen KL, Kamstrup PR, Deloukas P, Erdmann J, Kathiresan S, Samani NJ, Schunkert H, Watkins H; CARDIoGRAMplusC4D; Do R, Rader DJ, Johnson JA, Hazen SL, Quyyumi AA, Spertus JA, Pepine CJ, Franceschini N, Justice A, Reiner AP, Buyske S, Hindorff LA, Carty CL, North KE, Kooperberg C, Boerwinkle E, Young K, Graff M, Peters U, Absher D, Hsiung CA, Lee WJ, Taylor KD, Chen YH, Lee IT, Guo X, Chung RH, Hung YJ, Rotter JI, Juang JJ, Quertermous T, Wang TD, Rasheed A, Frossard P, Alam DS, Majumder AAS, Di Angelantonio E, Chowdhury R; EPIC-CVD; Chen YI, Nordestgaard BG, Assimes TL, Danesh J, Butterworth AS, Saleheen D. Fifteen new risk loci for coronary artery disease highlight arterial-wall-specific mechanisms. Nat Genet. 2017 Jul;49(7):1113-1119. doi: 10.1038/ng.3874. Epub 2017 May 22. |
| 28007143 | Background | Assimes TL, Roberts R. Genetics: Implications for Prevention and Management of Coronary Artery Disease. J Am Coll Cardiol. 2016 Dec 27;68(25):2797-2818. doi: 10.1016/j.jacc.2016.10.039. |
| 22983333 | Background | Vizirianakis IS, Fatouros DG. Personalized nanomedicine: paving the way to the practical clinical utility of genomics and nanotechnology advancements. Adv Drug Deliv Rev. 2012 Oct;64(13):1359-62. doi: 10.1016/j.addr.2012.09.034. Epub 2012 Sep 13. No abstract available. |
| 31104809 | Background | Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available. |
GESS trial [ClinicalTrials.gov Identifier: NCT03150680] was designed exclusively based on the protocol of the study "Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease" [CIP_PhD Rampidis Georgios_1.1] |
| 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 |