Trial Outcomes & Findings for Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG (NCT NCT03050489)
NCT ID: NCT03050489
Last Updated: 2023-01-13
Results Overview
Level of serum myeloperoxidase just after sternal closure
Recruitment status
COMPLETED
Target enrollment
336 participants
Primary outcome timeframe
Level of serum myeloperoxidase just after sternal closure
Results posted on
2023-01-13
Participant Flow
Recruitment period: 2015-2019 Location: North-West of Russia Medical clinic: Center of Cardiac Surgery of First Pavlov State Medical University
Participant milestones
| Measure |
On-Pump CABG
Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
On-Pump CABG.: Standard On-Pump CABG.
|
Off-Pump CABG
Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
Off-Pump CABG.: Standard Off-Pump CABG.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
181
|
27
|
|
Overall Study
COMPLETED
|
128
|
175
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Baseline characteristics by cohort
| Measure |
On-Pump CABG
n=128 Participants
Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass.
On-Pump CABG.: Standard On-Pump CABG.
|
Off-Pump CABG
n=175 Participants
Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass.
Off-Pump CABG.: Standard Off-Pump CABG.
|
BH-CABG MSC.
n=27 Participants
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
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 year
STANDARD_DEVIATION 7.1 • n=5 Participants
|
63.5 year
STANDARD_DEVIATION 7.3 • n=7 Participants
|
64.3 year
STANDARD_DEVIATION 8.95 • n=5 Participants
|
64.1 year
STANDARD_DEVIATION 7.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
330 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
128 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
330 Participants
n=4 Participants
|
|
Ejection Fraction
|
62 %
n=5 Participants
|
62 %
n=7 Participants
|
63 %
n=5 Participants
|
62 %
n=4 Participants
|
|
troponin I
|
0.014 ng/ml
n=5 Participants
|
0.0075 ng/ml
n=7 Participants
|
0.014 ng/ml
n=5 Participants
|
0.009 ng/ml
n=4 Participants
|
|
CRP
|
57.8 g/L
n=5 Participants
|
5.8 g/L
n=7 Participants
|
3.0 g/L
n=5 Participants
|
3.0 g/L
n=4 Participants
|
PRIMARY outcome
Timeframe: Level of serum myeloperoxidase just after sternal closurePopulation: Patients after coronary artery bypass grafting
Level of serum myeloperoxidase just after sternal closure
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Myeloperoxidase
|
144.71 g/L
Interval 95.04 to 284.92
|
184.3 g/L
Interval 135.01 to 250.0
|
66.5 g/L
Interval 41.33 to 135.82
|
SECONDARY outcome
Timeframe: Up to 30 days after surgical procedurePopulation: Patients with cardiac index \<2.2
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.
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Low Cardiac Output Syndrome
|
1 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During 30 days after procedure or morePopulation: Patients after coronary artery bypass grafting
Length of stay in intensive care unit after operation.
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Length of Stay in Intensive Care Unit
|
2 days
Interval 2.0 to 5.0
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: During 30 days after procedure or morePopulation: Patients after coronary artery bypass grafting
Length of stay in hospital
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Length of Stay in Hospital
|
13 days
Interval 10.0 to 15.0
|
13 days
Interval 11.0 to 15.0
|
12 days
Interval 10.0 to 13.0
|
SECONDARY outcome
Timeframe: Up to 30 days after procedurePopulation: Patients after coronary artery bypass grafting
Calculated according: Cumulative dose of inotrope = Days dose of inotrope \* days of administration of inotrope
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Cumulative Dose of Inotrope
|
0 mg*days
Interval 0.0 to 1.14
|
0 mg*days
Interval 0.0 to 0.12
|
0 mg*days
Interval 0.0 to 0.05
|
SECONDARY outcome
Timeframe: During 30 days after procedure or morePopulation: Patients after procedure
Period of inotrope administration
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Days of Administration of Inotrope
|
0 days
Interval 0.0 to 1.5
|
0 days
Interval 0.0 to 2.0
|
0 days
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: During 30 days after procedure or morePopulation: Patients after coronary artery bypas grafting
Length of pulmonary ventilation
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Pulmonary Ventilation
|
1 days
Interval 1.0 to 2.0
|
1 days
Interval 1.0 to 1.0
|
1 days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to 14 days after surgical procedurePopulation: Patients after coronary artery bypass grafting
Measured with echocardiography (Ejection Fraction)
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Systolic Function
|
63 units on a scale
Interval 55.0 to 65.0
|
62 units on a scale
Interval 59.0 to 66.0
|
62 units on a scale
Interval 55.0 to 67.0
|
SECONDARY outcome
Timeframe: Up to 14 days after surgical procedurePopulation: Patients after CABG
Measured with echocardiography (End-Diastolic Volume)
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Diastolic Function
|
109.5 ml
Interval 96.0 to 136.5
|
106.0 ml
Interval 81.0 to 131.0
|
97.0 ml
Interval 79.0 to 122.0
|
SECONDARY outcome
Timeframe: Up to 30 days after procedurePopulation: Patients after procedure
Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index\<2.2.
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Number of Participants With Reoperation
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Perioperative (before sternotomy and after sternal closure)Population: Patients after procedure
Serum creatinine level after surgical operation larger than 25% level before operation
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Renal Dysfunction
|
7 Participants
|
70 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after procedurePopulation: Patients after procedure
New onset atrial fibrillation after operation.
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Atrial Fibrillation.
|
8 Participants
|
27 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 30 days after procedurePopulation: Patients after procedure
Death after surgical procedure
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Death
|
0 Participants
|
7 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During 30 days after procedurePopulation: Patients after procedure
Stroke after surgical procedure
Outcome measures
| Measure |
Pump-assisted CABG
n=27 Participants
Pump-assisted CABG
|
On-pump CABG
n=128 Participants
On-pump CABG
|
Off-pump CABG
n=175 Participants
Off-pump CABG
|
|---|---|---|---|
|
Stroke
|
3 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
On-pump CABG
Serious events: 15 serious events
Other events: 1 other events
Deaths: 15 deaths
Off-pump CABG
Serious events: 15 serious events
Other events: 0 other events
Deaths: 15 deaths
Pump-assisted CABG
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
On-pump CABG
n=128 participants at risk
On-pump CABG
|
Off-pump CABG
n=175 participants at risk
Off-pump CABG
|
Pump-assisted CABG
n=27 participants at risk
Pump-assisted CABG
|
|---|---|---|---|
|
Cardiac disorders
Low cardiac output synfrome
|
11.7%
15/128 • Number of events 15 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
8.6%
15/175 • Number of events 15 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
3.7%
1/27 • Number of events 1 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
Other adverse events
| Measure |
On-pump CABG
n=128 participants at risk
On-pump CABG
|
Off-pump CABG
n=175 participants at risk
Off-pump CABG
|
Pump-assisted CABG
n=27 participants at risk
Pump-assisted CABG
|
|---|---|---|---|
|
Nervous system disorders
Stroke
|
0.78%
1/128 • Number of events 1 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
0.00%
0/175 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
3.7%
1/27 • Number of events 1 • 30 days follow up
All-Cause Mortality: The occurrence of death due to any cause. Serious Adverse Events. 15 participants died in both the "On-pump CABG" and "Off-pump CABG" Arms/Groups.
|
Additional Information
Nikolay Bunenkov
First State Pavlov Medical University
Phone: +7-950-028-17-40
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place