Outcome After Coronary Artery Bypass Grafting

Recruiting

• Conditions: Coronary Artery Disease; Angina Pectoris; Myocardial Infarction
• Interventions: Procedure: Coronary artery bypass surgery

• Registration Number: NCT02319083
• Lead Sponsor: University of Oulu

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-23
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Study Start: 2015-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07
• Primary Completion: 2015-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary artery bypass surgery	Coronary artery bypass surgery	Patients undergoing coronary artery bypass surgery.

Primary Outcome Measures

Name	Time	Method
Mortality	The outcome measure will be assessed at time points up to 10 years after surgery	Any death occurring after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland