Evaluation of Outcomes of Coronary Artery Bypass Grafting.

Study Overview
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Brief Summary
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Evaluation of outcomes of coronary artery bypass grafting.

Detailed Description
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Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump assisted as well as bimammary coronary artery bypass grafting. Objective: To assess myocardial ischemic-reperfusion damage during different kinds of CABG. To assess complications after during different kinds of CABG.

Official Title
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Evaluation of Outcomes of Coronary Artery Bypass Grafting.

Conditions
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Ischemic Heart Disease, Coronary Artery Bypass Grafting

Intervention / Treatment
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* Procedure: On-pump CABG.
* Procedure: Off-pump CABG.
* Procedure: Pump-assisted CABG.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic heart disease with indications for coronary artery bypass grafting. Exclusion Criteria: valve disease

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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: On-pump CABG.<br>On-pump CABG. | Procedure: On-pump CABG.<br>* On-pump coronary artery bypass grafting.<br>|
| Other: Off-pump CABG.<br>Off-pump CABG. | Procedure: Off-pump CABG.<br>* Off-pump coronary artery bypass grafting.<br>|
| Other: Pump-assisted CABG.<br>Pump-assisted CABG. | Procedure: Pump-assisted CABG.<br>* Pump-assisted CABG.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death. | Death during in-stay. | 30 days during in stay. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death over 1 year after CABG. | Death over 1 year after CABG. | 1 year. | 
| Death over 3 year after CABG. | Death over 3 year after CABG. | within 3 years. | 
| Death over 5 year after CABG. | Death over 5 year after CABG. | within 5 years. | 
| Acute myocardial infarction after CABG. | Acute myocardial infarction (Criteria: troponin I>10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index<2.3). | within 30 days after CABG | 
| Acute myocardial infarction after CABG. | Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG). | within 1 year after CABG | 
| Acute myocardial infarction after CABG. | Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG). | within 3 years after CABG | 
| Acute myocardial infarction after CABG. | Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG). | within 5 years after CABG | 
| Shunt dysfunction during 30 days after CABG. | Criteria: Stenosis or occlusion of graft on coronary angiography. | within 30 days after CABG | 
| Shunt dysfunction during 1 year after CABG. | Criteria: Stenosis or occlusion of graft on coronary angiography. | within 1 year after CABG | 
| Shunt dysfunction during 3 years after CABG. | Criteria: Stenosis or occlusion of graft on coronary angiography. | within 3 years after CABG | 
| Shunt dysfunction during 5 years after CABG. | Criteria: Stenosis or occlusion of graft on coronary angiography. | within 5 years after CABG | 
| Stroke. | Stroke after CABG (Record of neurologist in medical history or/and MRI findings). | within 30 days after CABG | 
| Renal Dysfunction. | Increase serum creatinine level greater than 25% of reference value after CABG. | within 30 days after CABG | 
| Atrial fibrillation. | New onset of atrial fibrillation after CABG (ECG findings: f-waves). | within 30 days after CABG | 
| IABP | Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3)) | within 30 days after CABG | 
| Infection or febrile. | Infection or febrile (leucocytosis > 9.0 more than 7 days after CABG or CRP > 10 or t>37.0 more than 7 days after CABG). | within 30 days after CABG | 
| Residual myocardial ischemia. | New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion). | within 30 days after CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Heart Disease, coronary artery bypass grafting, on-pump CABG, off-pump CABG, pump - assisted CABG, myeloperoxidase after CABG