Coronary Artery DiseaseE-CABGNCT02319083
Outcome After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Oulu at 1 site in Finland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Angina Pectoris
- What is being tested?
- Coronary artery bypass surgery
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes any patient undergoing isolated coronary artery bypass surgery.
Who may be able to join
- 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.
Who cannot join
- Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Fausto Biancari, Professor, +358407333973, faustobiancari@yahoo.it
About this study
Official title: 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).
Read the 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.
- Being tested
- Coronary artery bypass surgery
- Keywords
- CABG, Coronary artery bypass surgery, Coronary artery bypass grafting, Coronary surgery, Myocardial infarction, Coronary artery disease, Off-pump, EuroSCORE
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass surgeryProcedure or surgery
Also called Coronary artery bypass grafting
Patients will undergo coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery bypass surgery | Patients undergoing coronary artery bypass surgery. Receives: Procedure: Coronary artery bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Any death occurring after surgery
Measured: The outcome measure will be assessed at time points up to 10 years after surgery
Secondary outcomes (19)
Stroke
Any ischemic brain injury occurring after surgery and lasting > 24 hours
Measured: 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
Measured: Participants will be followed for the duration of hospital stay (expected: 10 days)
Intra-aortic balloon pump
Use of intra-aortic balloon pump for acute heart failure after surgery
Measured: 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
Measured: Participants will be followed for the duration of hospital stay (expected: 10 days)
Repeat revascularization
Any repeat myocardial revascularization procedure performed after surgery
Measured: 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
Measured: Participants will be followed up for 3 months after surgery
Blood losses
Amont of blood losses from drainages 12 hours after surgery
Measured: Participants will be followed 12 hours after surgery
Nadir hematocrit
Lowest hematocrit level during the operation day
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of hospital stay (expected: 10 days)
Resternotomy for bleeding
Re-exploration for excessive bleeding
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of hospital stay (expected: 10 days)
Pericardial effusion
Pericardial effusion requiring medical or surgical treatment
Measured: Participants will be followed up to 3 months after surgery.
Postoperative use of antibiotics
Postoperative use of antibiotics for postoperative infection
Measured: 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
Measured: Participants will be followed for the duration of hospital stay (expected: 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona, Ospedali Riuniti Trieste, University of Catania, University of Leicester, Centre Hospitalier Universitaire de Besancon, Karolinska Institutet, San Camillo Hospital, Rome, Rennes University Hospital, S. Anna Hospital, Paracelsus Medical University, University of Campania Luigi Vanvitelli, University of Parma, University of Bari, Centro Cardiologico Monzino, University of Hamburg-Eppendorf, University of Genova
- Responsible party
- Principal investigator, Fausto Biancari, University of Oulu
- Investigators
- Fausto Biancari, Professor, Study chair, University of Oulu, Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319083
- Sponsor's protocol ID
- 1
- Acronym
- E-CABG
- Status last verified
- Jul 2015
- First submitted
- 23 Nov 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32442254Biancari 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.
PubMed 31957634Khodabandeh 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.
PubMed 30527774Santarpino 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.
PubMed 30197287Reichart 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.
PubMed 29897529Mariscalco 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.
PubMed 29440275Biancari 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.
PubMed 27904903Biancari 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.
PubMed 26123033
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-CABG: European Multicenter Study on the Outcome After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02319083
- Acronym / sponsor ID
- E-CABG / 1
- Keywords
- CABG, Coronary artery bypass surgery, Coronary artery bypass grafting, Coronary surgery, Myocardial infarction, Coronary artery disease, Off-pump, EuroSCORE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Universita di Verona, Ospedali Riuniti Trieste, University of Catania, University of Leicester, Centre Hospitalier Universitaire de Besancon, Karolinska Institutet, San Camillo Hospital, Rome, Rennes University Hospital, S. Anna Hospital, Paracelsus Medical University, University of Campania Luigi Vanvitelli, University of Parma, University of Bari, Centro Cardiologico Monzino, University of Hamburg-Eppendorf, University of Genova
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary artery bypass surgery | – | Procedure: Coronary artery bypass surgeryPatients undergoing coronary artery bypass surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes any patient undergoing isolated coronary artery bypass surgery.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass surgeryAlso: Coronary artery bypass graftingPatients will undergo coronary artery bypass grafting | Procedure or surgery | Coronary artery bypass surgery |
Primary outcome
Mortality
Time frame: The outcome measure will be assessed at time points up to 10 years after surgery
Any death occurring after surgery
19 secondary outcomes
Stroke
Time frame: The outcome measure will be assessed at time points up to 10 years after surgery
Prolonged use of inotropes
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Intra-aortic balloon pump
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
ECMO
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Repeat revascularization
Time frame: The outcome measure will be assessed at time points up to 10 years after surgery
Wound infection
Time frame: Participants will be followed up for 3 months after surgery
Blood losses
Time frame: Participants will be followed 12 hours after surgery
Nadir hematocrit
Time frame: Participants will be followed during the operation day
Use of blood products
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Use of prothrombotic drugs
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Resternotomy for bleeding
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Atrial fibrillation
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Renal replacement therapy
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Highest level of serum creatinine
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Myocardial infarction
Time frame: The outcome measure will be assessed at time point up to 10 years after surgery
Length of stay in the intensive care unit
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Pericardial effusion
Time frame: Participants will be followed up to 3 months after surgery.
Postoperative use of antibiotics
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Gastrointestinal complications
Time frame: Participants will be followed for the duration of hospital stay (expected: 10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Derived from this study: PubMed 32442254Rubino 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.
- Derived from this study: PubMed 31957634Biancari 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.
- Derived from this study: PubMed 30527774Khodabandeh 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.
- Derived from this study: PubMed 30197287Santarpino 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.
- Derived from this study: PubMed 29897529Reichart 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.
- Derived from this study: PubMed 29440275Mariscalco 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.
- Derived from this study: PubMed 27904903Biancari 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.
- Derived from this study: PubMed 26123033Biancari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Biancari, Professor study chair
University of Oulu, Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fausto Biancari, Professor (+358407333973, faustobiancari@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: The outcome measure will be assessed at time points up to 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319083, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.