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Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. |
| |
| Off-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass. |
| |
| BH-CABG MSC. | Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-Pump CABG. | Procedure | Standard On-Pump CABG. |
| |
| Off-Pump CABG. |
| Measure | Description | Time Frame |
|---|---|---|
| Myeloperoxidase | Level of serum myeloperoxidase just after sternal closure | Level of serum myeloperoxidase just after sternal closure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days after surgical procedure |
| Length of Stay in Intensive Care Unit |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death after surgical procedure | During 30 days after procedure |
| Stroke | Stroke after surgical procedure | During 30 days after procedure |
Inclusion Criteria:
Exclusion Criteria:
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Patients with ischemic heart disease.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander S Nemkov, PhD, MD | PSPbGMU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Pavlov State Medical University of St. Petersburg | Saint Petersburg | 197089 | Russia |
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Recruitment period: 2015-2019 Location: North-West of Russia Medical clinic: Center of Cardiac Surgery of First Pavlov State Medical University
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| ID | Title | Description |
|---|---|---|
| FG000 | On-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. On-Pump CABG.: Standard On-Pump CABG. |
| FG001 | Off-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass. Off-Pump CABG.: Standard Off-Pump CABG. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | On-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed with cardiopulmonary bypass. On-Pump CABG.: Standard On-Pump CABG. |
| BG001 | Off-Pump CABG | Patients with coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass. Off-Pump CABG.: Standard Off-Pump CABG. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Myeloperoxidase | Level of serum myeloperoxidase just after sternal closure | Patients after coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | g/L | Level of serum myeloperoxidase just after sternal closure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | On-pump CABG | On-pump CABG | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low cardiac output synfrome | Cardiac disorders | SNOMED CT | Systematic Assessment | Low cardiac output synfrome when cardiac index <2.2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | SNOMED CT | Systematic Assessment |
Unequal amount of participants in arms (few patients were enrolled in off-pump arm).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikolay Bunenkov | First State Pavlov Medical University | +7-950-028-17-40 | bunenkov2006@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2016 | Oct 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
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Serum from central vein.
| Procedure |
Standard Off-Pump CABG. |
|
| BH-CABG MSC. | Procedure | Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation |
|
Length of stay in intensive care unit after operation. |
| During 30 days after procedure or more |
| Length of Stay in Hospital | Length of stay in hospital | During 30 days after procedure or more |
| Cumulative Dose of Inotrope | Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope | Up to 30 days after procedure |
| Days of Administration of Inotrope | Period of inotrope administration | During 30 days after procedure or more |
| Pulmonary Ventilation | Length of pulmonary ventilation | During 30 days after procedure or more |
| Systolic Function | Measured with echocardiography (Ejection Fraction) | Up to 14 days after surgical procedure |
| Diastolic Function | Measured with echocardiography (End-Diastolic Volume) | Up to 14 days after surgical procedure |
| Number of Participants With Reoperation | Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2. | Up to 30 days after procedure |
| Renal Dysfunction | Serum creatinine level after surgical operation larger than 25% level before operation | Perioperative (before sternotomy and after sternal closure) |
| Atrial Fibrillation. | New onset atrial fibrillation after operation. | Up to 30 days after procedure |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ejection Fraction | Median | Inter-Quartile Range | % |
|
| troponin I | Median | Inter-Quartile Range | ng/ml |
|
| CRP | C-reactive protein | Median | Inter-Quartile Range | g/L |
|
| OG002 |
| 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 |
|
|
| 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. | Patients with cardiac index <2.2 | Posted | Count of Participants | Participants | Up to 30 days after surgical procedure |
|
|
|
| Secondary | Length of Stay in Intensive Care Unit | Length of stay in intensive care unit after operation. | Patients after coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | days | During 30 days after procedure or more |
|
|
|
| Secondary | Length of Stay in Hospital | Length of stay in hospital | Patients after coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | days | During 30 days after procedure or more |
|
|
|
| Secondary | Cumulative Dose of Inotrope | Calculated according: Cumulative dose of inotrope = Days dose of inotrope * days of administration of inotrope | Patients after coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | mg*days | Up to 30 days after procedure |
|
|
|
| Secondary | Days of Administration of Inotrope | Period of inotrope administration | Patients after procedure | Posted | Median | 95% Confidence Interval | days | During 30 days after procedure or more |
|
|
|
| Secondary | Pulmonary Ventilation | Length of pulmonary ventilation | Patients after coronary artery bypas grafting | Posted | Median | Inter-Quartile Range | days | During 30 days after procedure or more |
|
|
|
| Secondary | Systolic Function | Measured with echocardiography (Ejection Fraction) | Patients after coronary artery bypass grafting | Posted | Median | Inter-Quartile Range | units on a scale | Up to 14 days after surgical procedure |
|
|
|
| Secondary | Diastolic Function | Measured with echocardiography (End-Diastolic Volume) | Patients after CABG | Posted | Median | 95% Confidence Interval | ml | Up to 14 days after surgical procedure |
|
|
|
| Secondary | Number of Participants With Reoperation | Number of participants with reoperation due to cardiac complication. Cardiac complication: graft dysfunction with cardiac index<2.2. | Patients after procedure | Posted | Count of Participants | Participants | Up to 30 days after procedure |
|
|
|
| Secondary | Renal Dysfunction | Serum creatinine level after surgical operation larger than 25% level before operation | Patients after procedure | Posted | Count of Participants | Participants | Perioperative (before sternotomy and after sternal closure) |
|
|
|
| Secondary | Atrial Fibrillation. | New onset atrial fibrillation after operation. | Patients after procedure | Posted | Count of Participants | Participants | Up to 30 days after procedure |
|
|
|
| Other Pre-specified | Death | Death after surgical procedure | Patients after procedure | Posted | Count of Participants | Participants | During 30 days after procedure |
|
|
|
| Other Pre-specified | Stroke | Stroke after surgical procedure | Patients after procedure | Posted | Count of Participants | Participants | During 30 days after procedure |
|
|
|
| 128 |
| 15 |
| 128 |
| 1 |
| 128 |
| EG001 | Off-pump CABG | Off-pump CABG | 15 | 175 | 15 | 175 | 0 | 175 |
| EG002 | Pump-assisted CABG | Pump-assisted CABG | 0 | 27 | 1 | 27 | 1 | 27 |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |