Clinical trial NCT03315234: Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease
Official title: Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease in the Greek Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Cardiovascular Risk Factor
Coronary Arteriosclerosis
Keywords: SYNTAX score
Coronary Atherosclerosis
Coronary Artery Disease
SNPs
Genetics
Genetic Risk Score
Personalized Medicine
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: LABNET IAE - Private Reference Diagnostic Laboratory
First posted: 2017-10-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes
2. Patients giving voluntary written consent to participate in the study
3. Male or female patients between 18 years to 90 years at entry
4. Patients without previous history of CAD

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

Primary outcomes:
measure: Relationship between genetic risk variants and the SYNTAX score [All-comers population]
timeFrame: 12 months
Secondary outcomes:
measure: MACCEs
timeFrame: 12 months
measure: Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs
timeFrame: 12 months
measure: Ankle-Brachial Index
timeFrame: At hospital admission
measure: Left Ventricular Ejection Fraction
timeFrame: At hospital admission & 12 months after discharge from hospital
measure: Neutrophil to Lymphocyte Ratio
timeFrame: At hospital admission
measure: Red Cell Distribution Width
timeFrame: At hospital admission
measure: Mean Platelet Volume
timeFrame: At hospital admission
measure: Glomerular Filtration Rate
timeFrame: At hospital admission
measure: High Density Lipoprotein
timeFrame: At hospital admission
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: AHEPA University Hospital, 1st Cardiology Department - PhD candidate
name: Georgios Rampidis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1
name: Georgios Sianos, MD, PhD, FESC
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2
name: Charalambos Karvounis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3
name: Ioannis Vizirianakis, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.