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Outcome After Coronary Artery Bypass Grafting

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02319083
Acronym
E-CABG
Enrollment
4000
Registered
2014-12-18
Start date
2015-01-31
Completion date
2025-12-31
Last updated
2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Coronary Artery Disease, Myocardial Infarction

Keywords

CABG, Coronary artery bypass surgery, Coronary artery bypass grafting, Coronary surgery, Myocardial infarction, Coronary artery disease, Off-pump, EuroSCORE

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.

Interventions

PROCEDURECoronary artery bypass surgery

Patients will undergo coronary artery bypass grafting

Sponsors

Universita di Verona
CollaboratorOTHER
Ospedali Riuniti Trieste
CollaboratorOTHER
University of Catania
CollaboratorOTHER
University of Leicester
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
San Camillo Hospital, Rome
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
S. Anna Hospital
CollaboratorOTHER
Paracelsus Medical University
CollaboratorOTHER
University of Campania Luigi Vanvitelli
CollaboratorOTHER
University of Parma
CollaboratorOTHER
University of Bari
CollaboratorOTHER
Centro Cardiologico Monzino
CollaboratorOTHER
University of Hamburg-Eppendorf
CollaboratorOTHER
University of Genova
CollaboratorOTHER
University of Oulu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MortalityThe outcome measure will be assessed at time points up to 10 years after surgeryAny death occurring after surgery

Secondary

MeasureTime frameDescription
Prolonged use of inotropesParticipants will be followed for the duration of hospital stay (expected: 10 days)Use of inotropes \> 12 hours after surgery
Intra-aortic balloon pumpParticipants will be followed for the duration of hospital stay (expected: 10 days)Use of intra-aortic balloon pump for acute heart failure after surgery
ECMOParticipants will be followed for the duration of hospital stay (expected: 10 days)Use of extracorporeal membrane oxygenation for acute heart failure after surgery
Repeat revascularizationThe outcome measure will be assessed at time points up to 10 years after surgeryAny repeat myocardial revascularization procedure performed after surgery
Wound infectionParticipants will be followed up for 3 months after surgeryAny deep sternal or lower limb wound infection occurring after surgery
Blood lossesParticipants will be followed 12 hours after surgeryAmont of blood losses from drainages 12 hours after surgery
Nadir hematocritParticipants will be followed during the operation dayLowest hematocrit level during the operation day
Use of blood productsParticipants 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 drugsParticipants 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
StrokeThe outcome measure will be assessed at time points up to 10 years after surgeryAny ischemic brain injury occurring after surgery and lasting \> 24 hours
Atrial fibrillationParticipants 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 therapyParticipants 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 creatinineParticipants will be followed for the duration of hospital stay (expected: 10 days)Highest level of serum creatinine during the in-hospital stay
Myocardial infarctionThe outcome measure will be assessed at time point up to 10 years after surgeryMyocardial infarction (diagnosed by ECG and troponin monitoring) any time after surgery
Length of stay in the intensive care unitParticipants will be followed for the duration of hospital stay (expected: 10 days)Length of stay in the intensive care unit after surgery
Pericardial effusionParticipants will be followed up to 3 months after surgery.Pericardial effusion requiring medical or surgical treatment
Postoperative use of antibioticsParticipants will be followed for the duration of hospital stay (expected: 10 days)Postoperative use of antibiotics for postoperative infection
Gastrointestinal complicationsParticipants will be followed for the duration of hospital stay (expected: 10 days)Any gastrointestinal complication requiring medical or surgical treatment after surgery
Resternotomy for bleedingParticipants will be followed for the duration of hospital stay (expected: 10 days)Re-exploration for excessive bleeding

Countries

Finland

Contacts

Primary ContactFausto Biancari, Professor
faustobiancari@yahoo.it+358407333973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026