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Evaluation of Outcomes of Coronary Artery Bypass Grafting. (EOCABG)

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ClinicalTrials.gov Identifier: NCT03786939
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University

Brief Summary:
Evaluation of outcomes of coronary artery bypass grafting.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Coronary Artery Bypass Grafting Procedure: On-pump CABG. Procedure: Off-pump CABG. Procedure: Pump-assisted CABG. Not Applicable

Detailed Description:

Evaluation of outcomes of coronary artery bypass grafting (CABG) on-, off- pump, pump assisted as well as bimammary coronary artery bypass grafting.

Objective:

To assess myocardial ischemic-reperfusion damage during different kinds of CABG.

To assess complications after during different kinds of CABG.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Outcomes of Coronary Artery Bypass Grafting.
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : May 20, 2023
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
On-pump CABG.
On-pump CABG.
Procedure: On-pump CABG.
On-pump coronary artery bypass grafting.

Off-pump CABG.
Off-pump CABG.
Procedure: Off-pump CABG.
Off-pump coronary artery bypass grafting.

Pump-assisted CABG.
Pump-assisted CABG.
Procedure: Pump-assisted CABG.
Pump-assisted CABG.




Primary Outcome Measures :
  1. Death. [ Time Frame: 30 days during in stay. ]
    Death during in-stay.


Secondary Outcome Measures :
  1. Death over 1 year after CABG. [ Time Frame: 1 year. ]
    Death over 1 year after CABG.

  2. Death over 3 year after CABG. [ Time Frame: within 3 years. ]
    Death over 3 year after CABG.

  3. Death over 5 year after CABG. [ Time Frame: within 5 years. ]
    Death over 5 year after CABG.

  4. Acute myocardial infarction after CABG. [ Time Frame: within 30 days after CABG ]
    Acute myocardial infarction (Criteria: troponin I>10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index<2.3).

  5. Acute myocardial infarction after CABG. [ Time Frame: within 1 year after CABG ]
    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

  6. Acute myocardial infarction after CABG. [ Time Frame: within 3 years after CABG ]
    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

  7. Acute myocardial infarction after CABG. [ Time Frame: within 5 years after CABG ]
    Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).

  8. Shunt dysfunction during 30 days after CABG. [ Time Frame: within 30 days after CABG ]
    Criteria: Stenosis or occlusion of graft on coronary angiography.

  9. Shunt dysfunction during 1 year after CABG. [ Time Frame: within 1 year after CABG ]
    Criteria: Stenosis or occlusion of graft on coronary angiography.

  10. Shunt dysfunction during 3 years after CABG. [ Time Frame: within 3 years after CABG ]
    Criteria: Stenosis or occlusion of graft on coronary angiography.

  11. Shunt dysfunction during 5 years after CABG. [ Time Frame: within 5 years after CABG ]
    Criteria: Stenosis or occlusion of graft on coronary angiography.

  12. Stroke. [ Time Frame: within 30 days after CABG ]
    Stroke after CABG (Record of neurologist in medical history or/and MRI findings).

  13. Renal Dysfunction. [ Time Frame: within 30 days after CABG ]
    Increase serum creatinine level greater than 25% of reference value after CABG.

  14. Atrial fibrillation. [ Time Frame: within 30 days after CABG ]
    New onset of atrial fibrillation after CABG (ECG findings: f-waves).

  15. IABP [ Time Frame: within 30 days after CABG ]
    Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3))

  16. Infection or febrile. [ Time Frame: within 30 days after CABG ]
    Infection or febrile (leucocytosis > 9.0 more than 7 days after CABG or CRP > 10 or t>37.0 more than 7 days after CABG).

  17. Residual myocardial ischemia. [ Time Frame: within 30 days after CABG ]
    New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic heart disease with indications for coronary artery bypass grafting.

Exclusion Criteria:

  • valve disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786939


Contacts
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Contact: Alexander Nemkov, PhD +7-921-795-00-47 nemk_as@mail.ru
Contact: Vladimir Komok, PhD +7-904-632-19-00 vladimir_komok@mail.ru

Locations
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Russian Federation
First Pavlov State Medical University Recruiting
St. Petersburg, Russian Federation, 197089
Contact: Vladimir Komok, Ph.D    +7 904 632 19 00    vladimir_komok@mail.ru   
Contact: Nikolay Bunenkov    +7 921 795 00 45    bunenkov2006@gmail.com   
Principal Investigator: Nikolai Bunenkov         
Sub-Investigator: Aleksey Sokolov, PhD         
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Investigators
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Study Director: Alexander Nemkov, PhD First State Pavlov Medical University

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Responsible Party: St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT03786939     History of Changes
Other Study ID Numbers: №214 17-12-2018
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data are confidential.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Petersburg State Pavlov Medical University:
Ischemic Heart Disease
coronary artery bypass grafting
on-pump CABG
off-pump CABG
pump - assisted CABG
myeloperoxidase after CABG

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases