Outcome After Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

— E-CABG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319083
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2014
• Last updated: July 3, 2015
• Start date: January 2015
• Est. completion date: December 2025

Study information

• Verified date: July 2015
• Source: University of Oulu
• Contact: Fausto Biancari, Professor
• Phone: +358407333973
• Email: faustobiancari[@]yahoo.it
• Is FDA regulated: No
• Health authority: Finland: Data Protection Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2025
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Coronary artery bypass surgery
Patients will undergo coronary artery bypass grafting

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (17)

Lead Sponsor

Collaborator

University of Oulu

Centre Hospitalier Universitaire de Besancon, Centro Cardiologico Monzino, Karolinska Institutet, Ospedali Riuniti Trieste, Paracelsus Medical University, Rennes University Hospital, S. Anna Hospital, San Camillo Hospital, Rome, Second University of Naples, Universita di Verona, University of Bari, University of Catania, University of Genova, University of Hamburg, University of Leicester, University of Parma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Any death occurring after surgery	The outcome measure will be assessed at time points up to 10 years after surgery	No
Secondary	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	No
Secondary	Prolonged use of inotropes	Use of inotropes > 12 hours after surgery	Participants will be followed for the duration of hospital stay (expected: 10 days)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	Wound infection	Any deep sternal or lower limb wound infection occurring after surgery	Participants will be followed up for 3 months after surgery	No
Secondary	Blood losses	Amont of blood losses from drainages 12 hours after surgery	Participants will be followed 12 hours after surgery	No
Secondary	Nadir hematocrit	Lowest hematocrit level during the operation day	Participants will be followed during the operation day	No
Secondary	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)	No
Secondary	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)	No
Secondary	Resternotomy for bleeding	Re-exploration for excessive bleeding	Participants will be followed for the duration of hospital stay (expected: 10 days)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	Pericardial effusion	Pericardial effusion requiring medical or surgical treatment	Participants will be followed up to 3 months after surgery.	No
Secondary	Postoperative use of antibiotics	Postoperative use of antibiotics for postoperative infection	Participants will be followed for the duration of hospital stay (expected: 10 days)	No
Secondary	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)	Yes