Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Study Overview
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Brief Summary
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Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

Detailed Description
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Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

Official Title
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AMIRI-CABG: Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Conditions
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Ischemic Heart Disease, Coronary Artery Disease, Ischemic Reperfusion Injury, CABG

Intervention / Treatment
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* Procedure: On-Pump CABG.
* Procedure: Off-Pump CABG.
* Procedure: BH-CABG MSC.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic heart disease Exclusion Criteria: valve disease diabetes millitus

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On-Pump CABG<br>Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. | Procedure: On-Pump CABG.<br>* Standard On-Pump CABG.<br>|
| Off-Pump CABG<br>Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass. | Procedure: Off-Pump CABG.<br>* Standard Off-Pump CABG.<br>|
| BH-CABG MSC.<br>Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation. | Procedure: BH-CABG MSC.<br>* Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myeloperoxidase | Level of serum myeloperoxidase just after sternal closure | Level of serum myeloperoxidase just after sternal closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Cardiac Output Syndrome | Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI <2.2. | Up to 30 days after surgical procedure | 
| Length of Stay in Intensive Care Unit | Length of stay in intensive care unit after operation. | During 30 days after procedure or more | 
| Length of Stay in Hospital | Length of stay in hospital | During 30 days after procedure or more | 
| Cumulative Dose of Inotrope | Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope | Up to 30 days after procedure | 
| Days of Administration of Inotrope | Period of inotrope administration | During 30 days after procedure or more | 
| Pulmonary Ventilation | Length of pulmonary ventilation | During 30 days after procedure or more | 
| Systolic Function | Measured with echocardiography (Ejection Fraction) | Up to 14 days after surgical procedure | 
| Diastolic Function | Measured with echocardiography (End-Diastolic Volume) | Up to 14 days after surgical procedure | 
| Number of Participants With Reoperation | Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2. | Up to 30 days after procedure | 
| Renal Dysfunction | Serum creatinine level after surgical operation larger than 25% level before operation | Perioperative (before sternotomy and after sternal closure) | 
| Atrial Fibrillation. | New onset atrial fibrillation after operation. | Up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Off-Pump CABG, On-Pump CABG, ischemic-reperfusion injury during CABG, comparison of On- and Off- Pump CABG, Ischemic Heart Disease, Myocardial ischemia-reperfusion and myeloperoxidase, Myocardial ischemia-reperfusion biomarkers