NCT02319083

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

November 23, 2014

Last Update Submit

July 3, 2015

Conditions

Coronary Artery DiseaseMyocardial InfarctionAngina Pectoris

Keywords

CABGCoronary artery bypass surgeryCoronary artery bypass graftingCoronary surgeryMyocardial infarctionCoronary artery diseaseOff-pumpEuroSCORE

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Any death occurring after surgery

    The outcome measure will be assessed at time points up to 10 years after surgery

Secondary Outcomes (19)

  • Stroke

    The outcome measure will be assessed at time points up to 10 years after surgery

  • Prolonged use of inotropes

    Participants will be followed for the duration of hospital stay (expected: 10 days)

  • Intra-aortic balloon pump

    Participants will be followed for the duration of hospital stay (expected: 10 days)

  • ECMO

    Participants will be followed for the duration of hospital stay (expected: 10 days)

  • Repeat revascularization

    The outcome measure will be assessed at time points up to 10 years after surgery

  • +14 more secondary outcomes

Study Arms (1)

Coronary artery bypass surgery

Patients undergoing coronary artery bypass surgery.

Procedure: Coronary artery bypass surgery

Interventions

Coronary artery bypass surgeryPROCEDURE

Patients will undergo coronary artery bypass grafting

Also known as: Coronary artery bypass grafting
Coronary artery bypass surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

Related Publications (8)

  • 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.

    PMID: 32442254DERIVED

  • 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.

    PMID: 31957634DERIVED

  • 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.

    PMID: 30527774DERIVED

  • 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.

    PMID: 30197287DERIVED

  • 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.

    PMID: 29897529DERIVED

  • 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.

    PMID: 29440275DERIVED

  • 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.

    PMID: 27904903DERIVED

  • 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.

    PMID: 26123033DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionAngina Pectoris

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Fausto Biancari, Professor

    University of Oulu, Oulu, Finland

    STUDY CHAIR

Central Study Contacts

Fausto Biancari, Professor

CONTACT

+358407333973faustobiancari@yahoo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2014

First Posted

December 18, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2025

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

FI(1)