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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Greece1 site
  • Onassis Cardiac Surgery Centre

    Kallithea, Attica, 17674

Other trials in Greece

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.

  1. 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.
  2. 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.
  3. 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.

  1. 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.
  2. 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.
  3. 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.
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.

  1. 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.

  1. First posted5 Feb 2024
  2. Study start30 Oct 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2026 (estimated)

Resources

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)
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

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.

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