CABG, Coronary Artery Disease, Ischemic Heart Disease, Ischemic Reperfusion Injury
Conditions
Keywords
CABG, Off-Pump CABG, On-Pump CABG, ischemic-reperfusion injury during CABG, comparison of On- and Off- Pump CABG, Ischemic Heart Disease, Myocardial ischemia-reperfusion and myeloperoxidase, Myocardial ischemia-reperfusion biomarkers
Brief summary
Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.
Detailed description
Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.
Interventions
PROCEDUREOn-Pump CABG.
Standard On-Pump CABG.
PROCEDUREOff-Pump CABG.
Standard Off-Pump CABG.
PROCEDUREBH-CABG MSC.
Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Inclusion criteria
* ischemic heart disease
Exclusion criteria
* valve disease * diabetes millitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myeloperoxidase | Level of serum myeloperoxidase just after sternal closure | Level of serum myeloperoxidase just after sternal closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Cardiac Output Syndrome | Up to 30 days after surgical procedure | Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI \<2.2. |
| Length of Stay in Intensive Care Unit | During 30 days after procedure or more | Length of stay in intensive care unit after operation. |
| Length of Stay in Hospital | During 30 days after procedure or more | Length of stay in hospital |
| Cumulative Dose of Inotrope | Up to 30 days after procedure | Calculated according: Cumulative dose of inotrope = Days dose of inotrope \* days of administration of inotrope |
| Days of Administration of Inotrope | During 30 days after procedure or more | Period of inotrope administration |
| Pulmonary Ventilation | During 30 days after procedure or more | Length of pulmonary ventilation |
| Renal Dysfunction | Perioperative (before sternotomy and after sternal closure) | Serum creatinine level after surgical operation larger than 25% level before operation |
| Atrial Fibrillation. | Up to 30 days after procedure | New onset atrial fibrillation after operation. |
| Systolic Function | Up to 14 days after surgical procedure | Measured with echocardiography (Ejection Fraction) |
| Diastolic Function | Up to 14 days after surgical procedure | Measured with echocardiography (End-Diastolic Volume) |
| Number of Participants With Reoperation | Up to 30 days after procedure | Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index\<2.2. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | During 30 days after procedure | Death after surgical procedure |
| Stroke | During 30 days after procedure | Stroke after surgical procedure |
Countries
Russia
Participant flow
Recruitment details
Recruitment period: 2015-2019 Location: North-West of Russia Medical clinic: Center of Cardiac Surgery of First Pavlov State Medical University
Participants by arm
| Arm | Count |
|---|---|
| On-Pump CABG Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
On-Pump CABG.: Standard On-Pump CABG. | 128 |
| Off-Pump CABG Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
Off-Pump CABG.: Standard Off-Pump CABG. | 175 |
| BH-CABG MSC. Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation.
BH-CABG MSC.: Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation | 27 |
| Total | 330 |
Baseline characteristics
| Characteristic | Off-Pump CABG | Total | BH-CABG MSC. | On-Pump CABG |
|---|---|---|---|---|
| Age, Continuous | 63.5 year STANDARD_DEVIATION 7.3 | 64.1 year STANDARD_DEVIATION 7.2 | 64.3 year STANDARD_DEVIATION 8.95 | 63.5 year STANDARD_DEVIATION 7.1 |
| CRP | 5.8 g/L | 3.0 g/L | 3.0 g/L | 57.8 g/L |
| Ejection Fraction | 62 % | 62 % | 63 % | 62 % |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 175 Participants | 330 Participants | 27 Participants | 128 Participants |
| Region of Enrollment Russia | 175 Participants | 330 Participants | 27 Participants | 128 Participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 7 Participants | 33 Participants |
| Sex: Female, Male Male | 135 Participants | 250 Participants | 20 Participants | 95 Participants |
| troponin I | 0.0075 ng/ml | 0.009 ng/ml | 0.014 ng/ml | 0.014 ng/ml |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 15 / 128 | 15 / 175 | 0 / 27 |
| other Total, other adverse events | 1 / 128 | 0 / 175 | 1 / 27 |
| serious Total, serious adverse events | 15 / 128 | 15 / 175 | 1 / 27 |
Outcome results
Primary
Myeloperoxidase
Level of serum myeloperoxidase just after sternal closure
Time frame: Level of serum myeloperoxidase just after sternal closure
Population: Patients after coronary artery bypass grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Myeloperoxidase | 184.3 g/L |
| Off-Pump CABG | Myeloperoxidase | 66.5 g/L |
| BH-CABG MSC. | Myeloperoxidase | 144.71 g/L |
Secondary
Atrial Fibrillation.
New onset atrial fibrillation after operation.
Time frame: Up to 30 days after procedure
Population: Patients after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Atrial Fibrillation. | 27 Participants |
| Off-Pump CABG | Atrial Fibrillation. | 26 Participants |
| BH-CABG MSC. | Atrial Fibrillation. | 8 Participants |
Secondary
Cumulative Dose of Inotrope
Calculated according: Cumulative dose of inotrope = Days dose of inotrope \* days of administration of inotrope
Time frame: Up to 30 days after procedure
Population: Patients after coronary artery bypass grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Cumulative Dose of Inotrope | 0 mg*days |
| Off-Pump CABG | Cumulative Dose of Inotrope | 0 mg*days |
| BH-CABG MSC. | Cumulative Dose of Inotrope | 0 mg*days |
Secondary
Days of Administration of Inotrope
Period of inotrope administration
Time frame: During 30 days after procedure or more
Population: Patients after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Days of Administration of Inotrope | 0 days |
| Off-Pump CABG | Days of Administration of Inotrope | 0 days |
| BH-CABG MSC. | Days of Administration of Inotrope | 0 days |
Secondary
Diastolic Function
Measured with echocardiography (End-Diastolic Volume)
Time frame: Up to 14 days after surgical procedure
Population: Patients after CABG
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Diastolic Function | 106.0 ml |
| Off-Pump CABG | Diastolic Function | 97.0 ml |
| BH-CABG MSC. | Diastolic Function | 109.5 ml |
Secondary
Length of Stay in Hospital
Length of stay in hospital
Time frame: During 30 days after procedure or more
Population: Patients after coronary artery bypass grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Length of Stay in Hospital | 13 days |
| Off-Pump CABG | Length of Stay in Hospital | 12 days |
| BH-CABG MSC. | Length of Stay in Hospital | 13 days |
Secondary
Length of Stay in Intensive Care Unit
Length of stay in intensive care unit after operation.
Time frame: During 30 days after procedure or more
Population: Patients after coronary artery bypass grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Length of Stay in Intensive Care Unit | 2 days |
| Off-Pump CABG | Length of Stay in Intensive Care Unit | 2 days |
| BH-CABG MSC. | Length of Stay in Intensive Care Unit | 2 days |
Secondary
Low Cardiac Output Syndrome
Low cardiac output syndrome up to 30 days after procedure. Cardiac index (CI) was measured by invasive methods. Low cardiac output syndrome was registered when CI \<2.2.
Time frame: Up to 30 days after surgical procedure
Population: Patients with cardiac index \<2.2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Low Cardiac Output Syndrome | 15 Participants |
| Off-Pump CABG | Low Cardiac Output Syndrome | 15 Participants |
| BH-CABG MSC. | Low Cardiac Output Syndrome | 1 Participants |
Secondary
Number of Participants With Reoperation
Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index\<2.2.
Time frame: Up to 30 days after procedure
Population: Patients after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Number of Participants With Reoperation | 1 Participants |
| Off-Pump CABG | Number of Participants With Reoperation | 1 Participants |
| BH-CABG MSC. | Number of Participants With Reoperation | 0 Participants |
Secondary
Pulmonary Ventilation
Length of pulmonary ventilation
Time frame: During 30 days after procedure or more
Population: Patients after coronary artery bypas grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Pulmonary Ventilation | 1 days |
| Off-Pump CABG | Pulmonary Ventilation | 1 days |
| BH-CABG MSC. | Pulmonary Ventilation | 1 days |
Secondary
Renal Dysfunction
Serum creatinine level after surgical operation larger than 25% level before operation
Time frame: Perioperative (before sternotomy and after sternal closure)
Population: Patients after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Renal Dysfunction | 70 Participants |
| Off-Pump CABG | Renal Dysfunction | 49 Participants |
| BH-CABG MSC. | Renal Dysfunction | 7 Participants |
Secondary
Systolic Function
Measured with echocardiography (Ejection Fraction)
Time frame: Up to 14 days after surgical procedure
Population: Patients after coronary artery bypass grafting
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| On-Pump CABG | Systolic Function | 62 units on a scale |
| Off-Pump CABG | Systolic Function | 62 units on a scale |
| BH-CABG MSC. | Systolic Function | 63 units on a scale |
Other Pre-specified
Death
Death after surgical procedure
Time frame: During 30 days after procedure
Population: Patients after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Death | 7 Participants |
| Off-Pump CABG | Death | 4 Participants |
| BH-CABG MSC. | Death | 0 Participants |
Other Pre-specified
Stroke
Stroke after surgical procedure
Time frame: During 30 days after procedure
Population: Patients after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| On-Pump CABG | Stroke | 3 Participants |
| Off-Pump CABG | Stroke | 6 Participants |
| BH-CABG MSC. | Stroke | 3 Participants |