Coronary Artery DiseaseNCT03315234
Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease
An observational study of Coronary Artery Disease and Cardiovascular Risk Factor, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Risk Factor, Coronary Arteriosclerosis
- What is being tested?
- SNPs associated with CAD
- How many people
- 270 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2016to 30 Jun 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease in the Greek Population
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.
- Being tested
- SNPs associated with CAD
- Keywords
- SYNTAX score, Coronary Atherosclerosis, Coronary Artery Disease, SNPs, Genetics, Genetic Risk Score, Personalized Medicine
- Medical subject headings
- Coronary Artery Disease, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNPs associated with CADGenetic
Genotyping will be carried out by Real-Time PCR
| Study group | Role | What they receive |
|---|---|---|
| SYNTAX score = 0 | Patients with nonobstructive CAD (≤50 % diameter stenosis) Receives: Genetic: SNPs associated with CAD | |
| 0 < SYNTAX score < 23 | Low SYNTAX group Receives: Genetic: SNPs associated with CAD | |
| SYNTAX score ≥ 23 | Intermediate-High SYNTAX group Receives: Genetic: SNPs associated with CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
MACCEs
Cardiovascular death, myocardial infarction, stent thrombosis, any re-intervention and stroke
Measured: 12 months
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.
Measured: 12 months
Ankle-Brachial Index
A tool for diagnosing peripheral artery disease but also an indicator of systemic atherosclerosis [represented by a single number]
Measured: At hospital admission
Left Ventricular Ejection Fraction
LVEF [%] as assessed by echocardiography
Measured: At hospital admission & 12 months after discharge from hospital
Neutrophil to Lymphocyte Ratio
NLR [represented by a single number]
Measured: At hospital admission
Red Cell Distribution Width
RDW [%]
Measured: At hospital admission
Mean Platelet Volume
MPV [fL]
Measured: At hospital admission
Glomerular Filtration Rate
GFR as assessed by CKD-EPI formula [mL/min/1.73m²]
Measured: At hospital admission
High Density Lipoprotein
HDL [mg/dL]
Measured: At hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Sep 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- LABNET IAE - Private Reference Diagnostic Laboratory
- Responsible party
- Principal investigator, Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki
- Investigators
- Georgios Rampidis, MD, MSc, Principal investigator, AHEPA University Hospital, 1st Cardiology Department - PhD candidateGeorgios Sianos, MD, PhD, FESC, Principal investigator, AHEPA University Hospital, 1st Cardiology Department - PhD Supervisor 1Charalambos Karvounis, MD, PhD, Principal investigator, AHEPA University Hospital, 1st Cardiology Department, Director - PhD Supervisor 2Ioannis Vizirianakis, PharmD, PhD, Principal investigator, Aristotle University of Thessaloniki, School of Pharmacy - PhD Supervisor 3
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315234
- Sponsor's protocol ID
- CIP_PhD Rampidis Georgios_1.1
- Status last verified
- Jun 2020
- First submitted
- 10 Oct 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 19758907Knowles 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 28856136Howson 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 28530674Assimes 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 28007143Vizirianakis 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 22983333Rampidis 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Genetic Polymorphisms and Clinical Parameters With the Complexity of Coronary Artery Disease in the Greek Population
- ClinicalTrials.gov ID
- NCT03315234
- Acronym / sponsor ID
- CIP_PhD Rampidis Georgios_1.1
- Keywords
- SYNTAX score, Coronary Atherosclerosis, Coronary Artery Disease, SNPs, Genetics, Genetic Risk Score, Personalized Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- LABNET IAE - Private Reference Diagnostic Laboratory
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYNTAX score = 0 | – | Genetic: SNPs associated with CADPatients with nonobstructive CAD (≤50 % diameter stenosis) |
| 0 < SYNTAX score < 23 | – | Genetic: SNPs associated with CADLow SYNTAX group |
| SYNTAX score ≥ 23 | – | Genetic: SNPs associated with CADIntermediate-High SYNTAX group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNPs associated with CADGenotyping will be carried out by Real-Time PCR | Genetic | 0 < SYNTAX score < 23, SYNTAX score = 0, SYNTAX score ≥ 23 |
Primary outcome
Relationship between genetic risk variants and the SYNTAX score [All-comers population]
Time frame: 12 months
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
9 secondary outcomes
MACCEs
Time frame: 12 months
Predictive value of combining a Genetic Risk Score & SYNTAX score for the prediction of 1-year MACCEs
Time frame: 12 months
Ankle-Brachial Index
Time frame: At hospital admission
Left Ventricular Ejection Fraction
Time frame: At hospital admission & 12 months after discharge from hospital
Neutrophil to Lymphocyte Ratio
Time frame: At hospital admission
Red Cell Distribution Width
Time frame: At hospital admission
Mean Platelet Volume
Time frame: At hospital admission
Glomerular Filtration Rate
Time frame: At hospital admission
High Density Lipoprotein
Time frame: At hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 19758907Sianos 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.
- Background: PubMed 28856136Knowles 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.
- Background: PubMed 28530674Howson 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.
- Background: PubMed 28007143Assimes 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.
- Background: PubMed 22983333Vizirianakis 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.
- Background: PubMed 31104809Rampidis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiovascular Risk Factor, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between genetic risk variants and the SYNTAX score [All-comers population] (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315234, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.