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

Primary Purpose

Ischemic Heart Disease, Coronary Artery Bypass Grafting

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
On-pump CABG.
Off-pump CABG.
Pump-assisted CABG.
Sponsored by
St. Petersburg State Pavlov Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Heart Disease focused on measuring Ischemic Heart Disease, coronary artery bypass grafting, on-pump CABG, off-pump CABG, pump - assisted CABG, myeloperoxidase after CABG

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • valve disease

Sites / Locations

  • First Pavlov State Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

On-pump CABG.

Off-pump CABG.

Pump-assisted CABG.

Arm Description

On-pump CABG.

Off-pump CABG.

Pump-assisted CABG.

Outcomes

Primary Outcome Measures

Death.
Death during in-stay.

Secondary Outcome Measures

Death over 1 year after CABG.
Death over 1 year after CABG.
Death over 3 year after CABG.
Death over 3 year after CABG.
Death over 5 year after CABG.
Death over 5 year after CABG.
Acute myocardial infarction after CABG.
Acute myocardial infarction (Criteria: troponin I>10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index<2.3).
Acute myocardial infarction after CABG.
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Acute myocardial infarction after CABG.
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Acute myocardial infarction after CABG.
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Shunt dysfunction during 30 days after CABG.
Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 1 year after CABG.
Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 3 years after CABG.
Criteria: Stenosis or occlusion of graft on coronary angiography.
Shunt dysfunction during 5 years after CABG.
Criteria: Stenosis or occlusion of graft on coronary angiography.
Stroke.
Stroke after CABG (Record of neurologist in medical history or/and MRI findings).
Renal Dysfunction.
Increase serum creatinine level greater than 25% of reference value after CABG.
Atrial fibrillation.
New onset of atrial fibrillation after CABG (ECG findings: f-waves).
IABP
Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3))
Infection or febrile.
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).
Residual myocardial ischemia.
New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).

Full Information

First Posted
December 20, 2018
Last Updated
October 25, 2022
Sponsor
St. Petersburg State Pavlov Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03786939
Brief Title
Evaluation of Outcomes of Coronary Artery Bypass Grafting.
Acronym
EOCABG
Official Title
Evaluation of Outcomes of Coronary Artery Bypass Grafting.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Artery Bypass Grafting
Keywords
Ischemic Heart Disease, coronary artery bypass grafting, on-pump CABG, off-pump CABG, pump - assisted CABG, myeloperoxidase after CABG

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
On-pump CABG.
Arm Type
Other
Arm Description
On-pump CABG.
Arm Title
Off-pump CABG.
Arm Type
Other
Arm Description
Off-pump CABG.
Arm Title
Pump-assisted CABG.
Arm Type
Other
Arm Description
Pump-assisted CABG.
Intervention Type
Procedure
Intervention Name(s)
On-pump CABG.
Intervention Description
On-pump coronary artery bypass grafting.
Intervention Type
Procedure
Intervention Name(s)
Off-pump CABG.
Intervention Description
Off-pump coronary artery bypass grafting.
Intervention Type
Procedure
Intervention Name(s)
Pump-assisted CABG.
Intervention Description
Pump-assisted CABG.
Primary Outcome Measure Information:
Title
Death.
Description
Death during in-stay.
Time Frame
30 days during in stay.
Secondary Outcome Measure Information:
Title
Death over 1 year after CABG.
Description
Death over 1 year after CABG.
Time Frame
1 year.
Title
Death over 3 year after CABG.
Description
Death over 3 year after CABG.
Time Frame
within 3 years.
Title
Death over 5 year after CABG.
Description
Death over 5 year after CABG.
Time Frame
within 5 years.
Title
Acute myocardial infarction after CABG.
Description
Acute myocardial infarction (Criteria: troponin I>10+ST-elevation ECG+hemodynamic instability - record in medical history ot Cardiac Index<2.3).
Time Frame
within 30 days after CABG
Title
Acute myocardial infarction after CABG.
Description
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Time Frame
within 1 year after CABG
Title
Acute myocardial infarction after CABG.
Description
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Time Frame
within 3 years after CABG
Title
Acute myocardial infarction after CABG.
Description
Acute myocardial infarction (Criteria: troponin I>0.05+ST-elevation on ECG).
Time Frame
within 5 years after CABG
Title
Shunt dysfunction during 30 days after CABG.
Description
Criteria: Stenosis or occlusion of graft on coronary angiography.
Time Frame
within 30 days after CABG
Title
Shunt dysfunction during 1 year after CABG.
Description
Criteria: Stenosis or occlusion of graft on coronary angiography.
Time Frame
within 1 year after CABG
Title
Shunt dysfunction during 3 years after CABG.
Description
Criteria: Stenosis or occlusion of graft on coronary angiography.
Time Frame
within 3 years after CABG
Title
Shunt dysfunction during 5 years after CABG.
Description
Criteria: Stenosis or occlusion of graft on coronary angiography.
Time Frame
within 5 years after CABG
Title
Stroke.
Description
Stroke after CABG (Record of neurologist in medical history or/and MRI findings).
Time Frame
within 30 days after CABG
Title
Renal Dysfunction.
Description
Increase serum creatinine level greater than 25% of reference value after CABG.
Time Frame
within 30 days after CABG
Title
Atrial fibrillation.
Description
New onset of atrial fibrillation after CABG (ECG findings: f-waves).
Time Frame
within 30 days after CABG
Title
IABP
Description
Intra-Aortic Balloon Pump (non - planned intervention aftet CABG due to hemodinamic instability (Cardiac Index <2.3))
Time Frame
within 30 days after CABG
Title
Infection or febrile.
Description
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).
Time Frame
within 30 days after CABG
Title
Residual myocardial ischemia.
Description
New onset of myocardial contractility deterioration on echocardiography (with or without strain, documented hypokinetic or akinetic wall motion).
Time Frame
within 30 days after CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic heart disease with indications for coronary artery bypass grafting. Exclusion Criteria: valve disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Nemkov, PhD
Phone
+7-921-795-00-47
Email
nemk_as@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Komok, PhD
Phone
+7-904-632-19-00
Email
vladimir_komok@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Nemkov, PhD
Organizational Affiliation
First State Pavlov Medical University
Official's Role
Study Director
Facility Information:
Facility Name
First Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Komok, Ph.D
Phone
+7 904 632 19 00
Email
vladimir_komok@mail.ru
First Name & Middle Initial & Last Name & Degree
Nikolay Bunenkov
Phone
+7 921 795 00 45
Email
bunenkov2006@gmail.com
First Name & Middle Initial & Last Name & Degree
Nikolai Bunenkov
First Name & Middle Initial & Last Name & Degree
Aleksey Sokolov, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data are confidential.

Learn more about this trial

Evaluation of Outcomes of Coronary Artery Bypass Grafting.

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