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临床试验/NCT06242171
NCT06242171进行中(未招募)不适用

Prognostic Indices of Atheromatosis Severity and Coronary Artery Bypass Surgery Outcomes for Patients With Coronary Artery Disease

Onassis Cardiac Surgery Centre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Symptomatic coronary artery disease requiring surgical revascularisation

排除标准

  • Severe comorbidities; renal or liver failure, severe autoimmune disease Combined surgical procedures (valve surgery, aortic procedures, carotid surgery)

结局指标

主要结局

Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue

时间窗: 3 years

Correlation of the indices identified/ calculated with coronary artery disease severity and CABG outcome

次要结局

未报告次要终点

研究者

发起方
Onassis Cardiac Surgery Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aikaterini Gavalaki

Research Fellow

Onassis Cardiac Surgery Centre

研究点 (1)

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