Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Cardiovascular Risk Factor Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SYNTAX score = 0

Patients with nonobstructive CAD (≤50 % diameter stenosis)

SNPs associated with CAD

Intervention Type GENETIC

Genotyping will be carried out by Real-Time PCR

0 < SYNTAX score < 23

Low SYNTAX group

SNPs associated with CAD

Intervention Type GENETIC

Genotyping will be carried out by Real-Time PCR

SYNTAX score ≥ 23

Intermediate-High SYNTAX group

SNPs associated with CAD

Intervention Type GENETIC

Genotyping will be carried out by Real-Time PCR

Interventions

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SNPs associated with CAD

Genotyping will be carried out by Real-Time PCR

Intervention Type GENETIC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Georgios P Rampidis, MD, MSc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Rampidis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital, 1st Cardiology Department - PhD candidate

Georgios Sianos, MD, PhD, FESC

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1

Charalambos Karvounis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2

Ioannis Vizirianakis, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3

Locations

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AHEPA University Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND

PMID: 19758907 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 28856136 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 28530674 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 28007143 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 22983333 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 31104809 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

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" \[CIP\_PhD Rampidis Georgios\_1.1\]

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