ClinicalTrials.gg
Status unknownNCT03315234Updated Jun 9, 2020

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

An observational study in Coronary Artery Disease, Cardiovascular Risk Factor and Coronary Arteriosclerosis, sponsored by Aristotle University Of Thessaloniki. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by Aristotle University Of Thessaloniki · Observational

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
270
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 75 studies in Coronary Artery Disease with a site in Greece — 12 open to participants now, 18 under way, 3 of them phase 3. Coronary Artery Disease · Greece.

Enrollment
16th of 24
270 · median 727
Started
2016
with 2 others
Observational
24 of 75
6 open now
Registered
43rd of 75
by date
Lead sponsor
5 of 75
Aristotle University Of Thessaloniki

Among the 75 studies in Coronary Artery Disease with a site in Greece, this one is the 16th largest by enrollment of the 24 observational ones that give a count, is one of 3 that started in 2016, is one of 24 observational ones, and was the 43rd registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's enrollment of 270 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Open to participants now

12 of the 75 studies in Coronary Artery Disease with a site in Greece are open now.

All 12 open studies →

A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 75 studies in Coronary Artery Disease with a site in Greece, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Coronary Artery Disease
  • Cardiovascular Risk Factor
  • Coronary Arteriosclerosis

Keywords

  • SYNTAX score
  • Coronary Atherosclerosis
  • Coronary Artery Disease
  • SNPs
  • Genetics
  • Genetic Risk Score
  • Personalized Medicine
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 of \< 1 year
  5. Patients who refuse to give written consent for participation in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
270 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • GeneticSNPs associated with CAD

    Genotyping will be carried out by Real-Time PCR

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. MACCEs

    Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke

    Time frame: 12 months

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

    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.

    Time frame: 12 months

  3. Ankle-Brachial Index

    A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis \[represented by a single number\]

    Time frame: At hospital admission

  4. Left Ventricular Ejection Fraction

    LVEF \[%\] as assessed by echocardiography

    Time frame: At hospital admission & 12 months after discharge from hospital

  5. Neutrophil to Lymphocyte Ratio

    NLR \[represented by a single number\]

    Time frame: At hospital admission

  6. Red Cell Distribution Width

    RDW \[%\]

    Time frame: At hospital admission

  7. Mean Platelet Volume

    MPV \[fL\]

    Time frame: At hospital admission

  8. Glomerular Filtration Rate

    GFR as assessed by CKD-EPI formula \[mL/min/1.73m²\]

    Time frame: At hospital admission

  9. High Density Lipoprotein

    HDL \[mg/dL\]

    Time frame: At hospital admission

07

Study locations

1 site
  • AHEPA University Hospital
    Thessaloníki, 54636, Greece
08

References and documents

Publications

  • 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. PubMed 19758907 ↗
  • 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. PubMed 28856136 ↗
  • 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. PubMed 28530674 ↗
  • 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. PubMed 28007143 ↗
  • 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. PubMed 22983333 ↗
  • 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. PubMed 31104809 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Jun 2018, 21 months.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's 21 months is below that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 20, 2017
StartActual
Sep 1, 2016
Primary completionActual
Jun 30, 2018
CompletionEst.
Jun 30, 2021
Last update
Jun 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03315234
Collaborators
LABNET IAE - Private Reference Diagnostic Laboratory
Responsible party
Georgios P Rampidis, MD, MSc (Principal Investigator, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Oct 20, 2017
Start date
Sep 1, 2016
Primary completion
Jun 30, 2018
Completion
Jun 30, 2021 (estimated)
Last update
Jun 9, 2020

Study contacts

Georgios Rampidis, MD, MSc
principal investigator · AHEPA University Hospital, 1st Cardiology Department - PhD candidate
Georgios Sianos, MD, PhD, FESC
principal investigator · AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1
Charalambos Karvounis, MD, PhD
principal investigator · AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2
Ioannis Vizirianakis, PharmD, PhD
principal investigator · Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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