Outcome After Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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The E-CABG registry is a multicenter, European registry collecting data on the preoperative characteristics, treatment strategies and outcome of patients undergoing isolated coronary artery bypass grafting (CABG).

Detailed Description
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Improvements in the surgical treatment of coronary artery disease are possible only when implementation of current methods and development of new methods are based on the solid ground of large and reliable clinical data. Furthermore, clinical findings assume even more significance when detected in study populations from different institutions with heterogeneous referral pathways, baseline clinical characteristics and perioperative treatment strategies. The rationale of this European multicenter study is therefore to prospectively collect data on baseline characteristics, operative and anesthesiological methods and postoperative outcome of patients undergoing CABG in eleven cardiac surgery centers from five European countries. This multicenter prospective registrywill provide data to evaluate the prognostic impact of a number of patients' risk factors as well as the efficacy and safety of operative methods and drugs used during the pre-, peri- and postoperative period.

Official Title
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E-CABG: European Multicenter Study on the Outcome After Coronary Artery Bypass Grafting

Conditions
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Coronary Artery Disease, Myocardial Infarction, Angina Pectoris

Intervention / Treatment
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* Procedure: Coronary artery bypass surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of aged > 18 years undergoing isolated CABG for stable coronary artery disease or acute coronary syndrome. Patients undergoing Maze procedure will be included in this registry. Exclusion Criteria: Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary artery bypass surgery<br>Patients undergoing coronary artery bypass surgery. | Procedure: Coronary artery bypass surgery<br>* Patients will undergo coronary artery bypass grafting<br>* Other names: Coronary artery bypass grafting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Any death occurring after surgery | The outcome measure will be assessed at time points up to 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | Any ischemic brain injury occurring after surgery and lasting > 24 hours | The outcome measure will be assessed at time points up to 10 years after surgery | 
| Prolonged use of inotropes | Use of inotropes > 12 hours after surgery | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Intra-aortic balloon pump | Use of intra-aortic balloon pump for acute heart failure after surgery | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| ECMO | Use of extracorporeal membrane oxygenation for acute heart failure after surgery | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Repeat revascularization | Any repeat myocardial revascularization procedure performed after surgery | The outcome measure will be assessed at time points up to 10 years after surgery | 
| Wound infection | Any deep sternal or lower limb wound infection occurring after surgery | Participants will be followed up for 3 months after surgery | 
| Blood losses | Amont of blood losses from drainages 12 hours after surgery | Participants will be followed 12 hours after surgery | 
| Nadir hematocrit | Lowest hematocrit level during the operation day | Participants will be followed during the operation day | 
| Use of blood products | Use of any blood product (red blood cell, fresh frozen plasma, Octaplas, platelets) during the in-hospital stay | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Use of prothrombotic drugs | Perioperative use of cryoprecipitate, PCC and/or rFVIIa for excessive bleeding PCCs Perioperative use of rFVIIa, PCC, cryoprecipitate | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Resternotomy for bleeding | Re-exploration for excessive bleeding | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Atrial fibrillation | New episode of atrial fibrillation requiring or not cardioversion during the in-hospital stay | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Renal replacement therapy | Any renal replacement therapy during the in-hospital stay | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Highest level of serum creatinine | Highest level of serum creatinine during the in-hospital stay | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Myocardial infarction | Myocardial infarction (diagnosed by ECG and troponin monitoring) any time after surgery | The outcome measure will be assessed at time point up to 10 years after surgery | 
| Length of stay in the intensive care unit | Length of stay in the intensive care unit after surgery | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Pericardial effusion | Pericardial effusion requiring medical or surgical treatment | Participants will be followed up to 3 months after surgery. | 
| Postoperative use of antibiotics | Postoperative use of antibiotics for postoperative infection | Participants will be followed for the duration of hospital stay (expected: 10 days) | 
| Gastrointestinal complications | Any gastrointestinal complication requiring medical or surgical treatment after surgery | Participants will be followed for the duration of hospital stay (expected: 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Coronary artery bypass surgery, Coronary artery bypass grafting, Coronary surgery, Myocardial infarction, Coronary artery disease, Off-pump, EuroSCORE