Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06242171 |
| Other study ID # |
697/20.10.2020 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 30, 2020 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
January 2024 |
| Source |
Onassis Cardiac Surgery Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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).
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.
A) 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.
B) 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.
C) 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.
D) 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.
E) 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.
F) 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.
