Coronary Artery DiseaseNCT06242171
Prognostic Indices of Atheromatosis Severity and Coronary Artery Bypass Surgery Outcomes for Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease and Atheromatosis, run by Onassis Cardiac Surgery Centre at 1 site in Greece.
Trial summary
Coronary artery disease is a multifactorial disease. Traditional risk factors, such as obesity, diabetes, hypertension, stimulate the onset of an inflammatory process in the prone vessel and perivascular adipose tissue, which has not yet been clarified and is still being investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Atheromatosis
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 30 Oct 2020to 31 Aug 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that are scheduled to have coronary artery bypass graft surgery in Onassis Cardiac Surgery Centre
Who may be able to join
None listed.
Who cannot join
- Severe comorbidities; renal or liver failure, severe autoimmune disease Combined surgical procedures (valve surgery, aortic procedures, carotid surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Coronary artery disease is a multifactorial disease. Traditional risk factors, such as obesity, diabetes, hypertension, stimulate the onset of an inflammatory process in the prone vessel and perivascular adipose tissue, which has not yet been clarified and is still being investigated.
Coronary artery bypass grafting is an effective treatment of coronary artery disease, which has been shown to prolong survival. Perioperative analysis of the myocardial metabolic profile helps to identify appropriate markers and metabolites associated with early myocardial damage. This, in turn, helps to improve risk stratification by better understanding the mechanisms of the disease processes, in order to prevent postoperative myocardial infarction and its associated complications. Such indicators, which are related to the diagnosis and severity of coronary artery disease, as well as the prognosis of coronary artery bypass grafting, have been separately studied before, in the peripheral blood of patients with coronary artery disease, in healthy vascular tissues, such as mammary artery, compared to atherosclerotic tissue from the coronary artery, as well as in the epicardial adipose tissue, intraoperatively.
The aim of the proposed study is to investigate and evaluate metabolic factors and biomarkers preoperatively, intraoperatively and postoperatively, in patients undergoing coronary artery bypass grafting and their prognostic value regarding a) the severity of coronary artery disease (Gensini score, ejection fraction, acute coronary syndrome) and b) the outcome of surgery (indications of myocardial damage and / or infarction, low cardiac output syndrome and use of intraortic balloon pump, atrial fibrillation, 30-day mortality).
Read the detailed description
This is a prospective study, which will include 90 patients with diagnosed symptomatic coronary artery disease, who are scheduled to undergo coronary artery bypass surgery at the Onassis Cardiac Surgery Center. Patients with other cardiovascular diseases (valvular pathologies or aortic diseases) will not be included in the study.
- Upon admission in hospital, patients will be informed and will sign their consent to participate in the research protocol. Subsequently, a complete medical history will be obtained, including risk factors, comorbidities, and medical treatment. Gensini score of coronary artery disease severity, ejection fraction, and history of acute coronary syndrome will also be recorded.
- Preoperatively, a blood sample will be taken from a peripheral vein, part of which will be stored in RNA preservation tubes, and another part will be centrifuged in the Biochemistry Laboratory for plasma preservation.
- Intraoperatively, and in chronological order:
Blood samples will be taken through the coronary sinus catheter just before initiating extracorporeal circulation, divided into four parts: 1) in RNA preservation tube, 2) in a tube for plasma isolation, 3) in a tube for direct biochemical analysis (TnI, NT-proBNP, LDH), and 4) in a blood gas analyzer for pO2, pCO2, SpO2, Lactate acid, Hgb calculation.
Tissue samples will be taken from the harvested internal mammary artery, atheroma of the coronary vessel, whenever possible and epicardial adipose tissue.
Blood sample through the coronary sinus catheter immediately after extracorporeal circulation, divided into two parts: 1) in a tube for direct biochemical analysis, and 2) in a blood gas analyzer for pO2, pCO2, SpO2, Lactate acid, Hgb calculation.
Simultaneously, at the same time points, blood samples will be taken from the radial or brachial artery before and after extracorporeal circulation, and analyzed for blood gases.
- Postoperatively, a peripheral blood sample will be taken from the patient on the day of discharge; one part will be stored in RNA preservation tubes and another part centrifuged in the Biochemistry Laboratory for plasma preservation. In addition, intraoperative data (extracorporeal circulation duration, aortic cross-clamp time) and intervention outcome data (maximum troponin value and corresponding time, postoperative ejection fraction, atrial fibrillation event, intra-aortic pump placement, ICU stay duration, hospital stay duration, 30-day mortality) will be recorded.
- All whole blood, plasma, and tissue samples will be immediately stored at -80°C, grouped for each case, until sent to the Laboratory of Biological Chemistry at the University of Athens for detection and quantification of indicators such as extracellular matrix metalloproteinases (MMP-2, MMP-9, TIMP1, TIMP2), cytokines (IFNγ, IL-2, IL-4, IL-5, IL-6), and microRNA expression.
- After data collection, statistical analysis and correlation of various parameters measured in the coronary vessel, epicardial fat, patient's serum, and blood from the coronary sinus will be performed: 1) with the severity of coronary artery disease (Gensini score), and 2) with the short-term surgery outcome. Differences in the expression of study parameters between the coronary artery and internal mammary artery of the same patient will also be highlighted. These findings aim to identify new biomarkers of coronary artery disease and clarify the role of epicardial fat in the atheromatous process.
- Conditions
- Coronary Artery Disease, Atheromatosis
- Keywords
- coronary sinus sampling; coronary artery bypass graft surgery
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue
Correlation of the indices identified/ calculated with coronary artery disease severity and CABG outcome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start30 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onassis Cardiac Surgery Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aikaterini Gavalaki, Onassis Cardiac Surgery Centre
- Investigators
- Konstantinos Perreas, MD, PhD, Study director, Onassis Cardiac Surgery Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242171
- Sponsor's protocol ID
- 697/20.10.2020
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indices of Atheromatosis Severity and Coronary Artery Bypass Surgery Outcomes for Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06242171
- Acronym / sponsor ID
- 697/20.10.2020
- Conditions
- Coronary Artery Disease, Atheromatosis
- Keywords
- coronary sinus sampling; coronary artery bypass graft surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Onassis Cardiac Surgery CentreUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 5 Feb 2024 (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.
Coronary artery disease is a multifactorial disease. Traditional risk factors, such as obesity, diabetes, hypertension, stimulate the onset of an inflammatory process in the prone vessel and perivascular adipose tissue, which has not yet been clarified and is still being investigated.
Coronary artery bypass grafting is an effective treatment of coronary artery disease, which has been shown to prolong survival. Perioperative analysis of the myocardial metabolic profile helps to identify appropriate markers and metabolites associated with early myocardial damage. This, in turn, helps to improve risk stratification by better understanding the mechanisms of the disease processes, in order to prevent postoperative myocardial infarction and its associated complications. Such indicators, which are related to the diagnosis and severity of coronary artery disease, as well as the prognosis of coronary artery bypass grafting, have been separately studied before, in the peripheral blood of patients with coronary artery disease, in healthy vascular tissues, such as mammary artery, compared to atherosclerotic tissue from the coronary artery, as well as in the epicardial adipose tissue, intraoperatively.
The aim of the proposed study is to investigate and evaluate metabolic factors and biomarkers preoperatively, intraoperatively and postoperatively, in patients undergoing coronary artery bypass grafting and their prognostic value regarding a) the severity of coronary artery disease (Gensini score, ejection fraction, acute coronary syndrome) and b) the outcome of surgery (indications of myocardial damage and / or infarction, low cardiac output syndrome and use of intraortic balloon pump, atrial fibrillation, 30-day mortality).
Detailed description
This is a prospective study, which will include 90 patients with diagnosed symptomatic coronary artery disease, who are scheduled to undergo coronary artery bypass surgery at the Onassis Cardiac Surgery Center. Patients with other cardiovascular diseases (valvular pathologies or aortic diseases) will not be included in the study.
- Upon admission in hospital, patients will be informed and will sign their consent to participate in the research protocol. Subsequently, a complete medical history will be obtained, including risk factors, comorbidities, and medical treatment. Gensini score of coronary artery disease severity, ejection fraction, and history of acute coronary syndrome will also be recorded.
- Preoperatively, a blood sample will be taken from a peripheral vein, part of which will be stored in RNA preservation tubes, and another part will be centrifuged in the Biochemistry Laboratory for plasma preservation.
- Intraoperatively, and in chronological order:
Blood samples will be taken through the coronary sinus catheter just before initiating extracorporeal circulation, divided into four parts: 1) in RNA preservation tube, 2) in a tube for plasma isolation, 3) in a tube for direct biochemical analysis (TnI, NT-proBNP, LDH), and 4) in a blood gas analyzer for pO2, pCO2, SpO2, Lactate acid, Hgb calculation.
Tissue samples will be taken from the harvested internal mammary artery, atheroma of the coronary vessel, whenever possible and epicardial adipose tissue.
Blood sample through the coronary sinus catheter immediately after extracorporeal circulation, divided into two parts: 1) in a tube for direct biochemical analysis, and 2) in a blood gas analyzer for pO2, pCO2, SpO2, Lactate acid, Hgb calculation.
Simultaneously, at the same time points, blood samples will be taken from the radial or brachial artery before and after extracorporeal circulation, and analyzed for blood gases.
- Postoperatively, a peripheral blood sample will be taken from the patient on the day of discharge; one part will be stored in RNA preservation tubes and another part centrifuged in the Biochemistry Laboratory for plasma preservation. In addition, intraoperative data (extracorporeal circulation duration, aortic cross-clamp time) and intervention outcome data (maximum troponin value and corresponding time, postoperative ejection fraction, atrial fibrillation event, intra-aortic pump placement, ICU stay duration, hospital stay duration, 30-day mortality) will be recorded.
- All whole blood, plasma, and tissue samples will be immediately stored at -80°C, grouped for each case, until sent to the Laboratory of Biological Chemistry at the University of Athens for detection and quantification of indicators such as extracellular matrix metalloproteinases (MMP-2, MMP-9, TIMP1, TIMP2), cytokines (IFNγ, IL-2, IL-4, IL-5, IL-6), and microRNA expression.
- After data collection, statistical analysis and correlation of various parameters measured in the coronary vessel, epicardial fat, patient's serum, and blood from the coronary sinus will be performed: 1) with the severity of coronary artery disease (Gensini score), and 2) with the short-term surgery outcome. Differences in the expression of study parameters between the coronary artery and internal mammary artery of the same patient will also be highlighted. These findings aim to identify new biomarkers of coronary artery disease and clarify the role of epicardial fat in the atheromatous process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that are scheduled to have coronary artery bypass graft surgery in Onassis Cardiac Surgery Centre
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Severe comorbidities; renal or liver failure, severe autoimmune disease Combined surgical procedures (valve surgery, aortic procedures, carotid surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue
Time frame: 3 years
Correlation of the indices identified/ calculated with coronary artery disease severity and CABG outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
Konstantinos Perreas, MD, PhD study director
Onassis Cardiac Surgery Centre
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 Atheromatosis, run by Onassis Cardiac Surgery Centre 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 0 inclusion and 1 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 5 Feb 2024. 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?
Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2024.