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

NCT03315234 | Unknown DMC

• 1 other identifier: CIP_PhD Rampidis Georgios_1.1
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Cardiovascular Risk Factor; Coronary Arteriosclerosis

Keywords

SYNTAX score; Coronary Atherosclerosis; Coronary Artery Disease; SNPs; Genetics; Genetic Risk Score; Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• MACCEs

  12 months

• Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs

  12 months

• Ankle-Brachial Index

  At hospital admission

• Left Ventricular Ejection Fraction

  At hospital admission & 12 months after discharge from hospital

• Neutrophil to Lymphocyte Ratio

  At hospital admission

Study Arms (3)

SYNTAX score = 0

Patients with nonobstructive CAD (≤50 % diameter stenosis)

Genetic: SNPs associated with CAD

0 < SYNTAX score < 23

Low SYNTAX group

Genetic: SNPs associated with CAD

SYNTAX score ≥ 23

Intermediate-High SYNTAX group

Genetic: SNPs associated with CAD

Interventions

SNPs associated with CAD GENETIC

Genotyping will be carried out by Real-Time PCR

0 < SYNTAX score < 23; SYNTAX score = 0; SYNTAX score ≥ 23

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who are admitted in the Department of Cardiology in the AHEPA University General Hospital of Thessaloniki and undergo coronary angiography for clinical purposes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• LABNET IAE - Private Reference Diagnostic Laboratory: collaborator

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (6)

• 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.

  PMID: 19758907 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.

  PMID: 28856136 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.

  PMID: 28530674 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.

  PMID: 28007143 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.

  PMID: 22983333 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.

  PMID: 31104809 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Coronary Artery Disease; Genetic Risk Score

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 20, 2017
• Study Start: September 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

GR (1)