Clinical trial NCT02319083: Outcome After Coronary Artery Bypass Grafting
Official title: E-CABG: European Multicenter Study on the Outcome After Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Myocardial Infarction
Angina Pectoris
Keywords: CABG
Coronary artery bypass surgery
Coronary artery bypass grafting
Coronary surgery
Myocardial infarction
Coronary artery disease
Off-pump
EuroSCORE
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Universita di Verona
name: Ospedali Riuniti Trieste
name: University of Catania
name: University of Leicester
name: Centre Hospitalier Universitaire de Besancon
name: Karolinska Institutet
name: San Camillo Hospital, Rome
name: Rennes University Hospital
name: S. Anna Hospital
name: Paracelsus Medical University
name: University of Campania Luigi Vanvitelli
name: University of Parma
name: University of Bari
name: Centro Cardiologico Monzino
name: University of Hamburg-Eppendorf
name: University of Genova
First posted: 2014-12-18
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes any patient undergoing isolated coronary artery bypass surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: The outcome measure will be assessed at time points up to 10 years after surgery
Secondary outcomes:
measure: Stroke
timeFrame: The outcome measure will be assessed at time points up to 10 years after surgery
measure: Prolonged use of inotropes
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Intra-aortic balloon pump
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: ECMO
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Repeat revascularization
timeFrame: The outcome measure will be assessed at time points up to 10 years after surgery
measure: Wound infection
timeFrame: Participants will be followed up for 3 months after surgery
measure: Blood losses
timeFrame: Participants will be followed 12 hours after surgery
measure: Nadir hematocrit
timeFrame: Participants will be followed during the operation day
measure: Use of blood products
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Use of prothrombotic drugs
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Resternotomy for bleeding
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Atrial fibrillation
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Renal replacement therapy
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Highest level of serum creatinine
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Myocardial infarction
timeFrame: The outcome measure will be assessed at time point up to 10 years after surgery
measure: Length of stay in the intensive care unit
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Pericardial effusion
timeFrame: Participants will be followed up to 3 months after surgery.
measure: Postoperative use of antibiotics
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
measure: Gastrointestinal complications
timeFrame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu, Oulu, Finland
name: Fausto Biancari, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.