Outcome After Coronary Artery Bypass Grafting (E-CABG)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease; Angina Pectoris
• Intervention / Treatment: Procedure: Coronary artery bypass surgery

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Fausto Biancari, Professor; Phone Number: +358407333973; Email: faustobiancari@yahoo.it

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Fausto Biancari, Professor; Phone Number: +358407333973; Email: faustobiancari@yahoo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes any patient undergoing isolated coronary artery bypass surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary artery bypass surgery; Patients undergoing coronary artery bypass surgery.	Procedure: Coronary artery bypass surgery; Patients will undergo coronary artery bypass grafting; Other Names: Coronary artery bypass grafting

What is the study measuring?

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
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)
Resternotomy for bleeding	Re-exploration for excessive bleeding	Participants will be followed for the duration of hospital stay (expected: 10 days)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Karolinska Institutet; Universita di Verona; University of Campania "Luigi Vanvitelli"; Centre Hospitalier Universitaire de Besancon; Rennes University Hospital; University of Catania; University of Leicester; University of Hamburg-Eppendorf; University of Parma; Paracelsus Medical University; University of Genova; University of Bari; S. Anna Hospital; Centro Cardiologico Monzino; San Camillo Hospital, Rome; Ospedali Riuniti Trieste
• Investigators: Study Chair: Fausto Biancari, Professor, University of Oulu, Oulu, Finland

Publications and helpful links

General Publications

• Rubino AS, Nicolini F, Tauriainen T, Demal T, De Feo M, Onorati F, Faggian G, Bancone C, Perrotti A, Chocron S, Dalen M, Santarpino G, Fischlein T, Maselli D, Musumeci F, Santini F, Salsano A, Zanobini M, Saccocci M, Bounader K, Gatti G, Ruggieri VG, Mignosa C, Juvonen T, Mariscalco G, Biancari F. Failure to achieve a satisfactory cardiac outcome after isolated coronary surgery in low-risk patients. Interact Cardiovasc Thorac Surg. 2020 Jul 1;31(1):9-15. doi: 10.1093/icvts/ivaa062.
• Biancari F, Gatti G, Rosato S, Mariscalco G, Pappalardo A, Onorati F, Faggian G, Salsano A, Santini F, Ruggieri VG, Perrotti A, Santarpino G, Fischlein T, Saccocci M, Musumeci F, Rubino AS, De Feo M, Bancone C, Nicolini F, Kinnunen EM, Demal T, D'Errigo P, Juvonen T, Dalen M, Maselli D. Preoperative risk stratification of deep sternal wound infection after coronary surgery. Infect Control Hosp Epidemiol. 2020 Apr;41(4):444-451. doi: 10.1017/ice.2019.375. Epub 2020 Jan 20.
• Khodabandeh S, Biancari F, Kinnunen EM, Mariscalco G, Airaksinen J, Gherli R, Gatti G, Demal T, Onorati F, Faggian G, De Feo M, Santarpino G, Rubino AS, Maselli D, Salsano A, Nicolini F, Zanobini M, Ruggieri VG, Bounader K, Perrotti A, Dalen M. Perioperative Bleeding in Patients With Acute Coronary Syndrome Treated With Fondaparinux Versus Low-Molecular-Weight Heparin Before Coronary Artery Bypass Grafting. Am J Cardiol. 2019 Feb 15;123(4):565-570. doi: 10.1016/j.amjcard.2018.11.028. Epub 2018 Nov 24.
• Santarpino G, Nicolini F, De Feo M, Dalen M, Fischlein T, Perrotti A, Reichart D, Gatti G, Onorati F, Franzese I, Faggian G, Bancone C, Chocron S, Khodabandeh S, Rubino AS, Maselli D, Nardella S, Gherli R, Salsano A, Zanobini M, Saccocci M, Bounader K, Rosato S, Tauriainen T, Mariscalco G, Airaksinen J, Ruggieri VG, Biancari F. Prognostic Impact of Asymptomatic Carotid Artery Stenosis in Patients Undergoing Coronary Artery Bypass Grafting. Eur J Vasc Endovasc Surg. 2018 Nov;56(5):741-748. doi: 10.1016/j.ejvs.2018.07.042. Epub 2018 Sep 6.
• Reichart D, Rosato S, Nammas W, Onorati F, Dalen M, Castro L, Gherli R, Gatti G, Franzese I, Faggian G, De Feo M, Khodabandeh S, Santarpino G, Rubino AS, Maselli D, Nardella S, Salsano A, Nicolini F, Zanobini M, Saccocci M, Bounader K, Kinnunen EM, Tauriainen T, Airaksinen J, Seccareccia F, Mariscalco G, Ruggieri VG, Perrotti A, Biancari F. Clinical frailty scale and outcome after coronary artery bypass grafting. Eur J Cardiothorac Surg. 2018 Dec 1;54(6):1102-1109. doi: 10.1093/ejcts/ezy222.
• Mariscalco G, Rosato S, Serraino GF, Maselli D, Dalen M, Airaksinen JKE, Reichart D, Zanobini M, Onorati F, De Feo M, Gherli R, Santarpino G, Rubino AS, Gatti G, Nicolini F, Santini F, Perrotti A, Bruno VD, Ruggieri VG, Biancari F. Prior Percutaneous Coronary Intervention and Mortality in Patients Undergoing Surgical Myocardial Revascularization: Results From the E-CABG (European Multicenter Study on Coronary Artery Bypass Grafting) With a Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2018 Feb;11(2):e005650. doi: 10.1161/CIRCINTERVENTIONS.117.005650.
• Biancari F, Brascia D, Onorati F, Reichart D, Perrotti A, Ruggieri VG, Santarpino G, Maselli D, Mariscalco G, Gherli R, Rubino AS, De Feo M, Gatti G, Santini F, Dalen M, Saccocci M, Kinnunen EM, Airaksinen JK, D'Errigo P, Rosato S, Nicolini F. Prediction of severe bleeding after coronary surgery: the WILL-BLEED Risk Score. Thromb Haemost. 2017 Feb 28;117(3):445-456. doi: 10.1160/TH16-09-0721. Epub 2016 Dec 1.
• Biancari F, Ruggieri VG, Perrotti A, Svenarud P, Dalen M, Onorati F, Faggian G, Santarpino G, Maselli D, Dominici C, Nardella S, Musumeci F, Gherli R, Mariscalco G, Masala N, Rubino AS, Mignosa C, De Feo M, Della Corte A, Bancone C, Chocron S, Gatti G, Gherli T, Kinnunen EM, Juvonen T. European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications. J Cardiothorac Surg. 2015 Jun 30;10:90. doi: 10.1186/s13019-015-0292-z.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 23, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 3, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Coronary artery disease; Myocardial infarction; CABG; Off-pump; Coronary artery bypass grafting; Coronary artery bypass surgery; EuroSCORE; Coronary surgery
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris
• Other Study ID Numbers: 1