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This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation.
Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival.
Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow.
The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC Group | Experimental | Three cycles of remote ischemic conditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation); First three cycles the patient will receive 24 hours preoperatively, second three cycles the patient will receive after the induction of general anesthesia but before skin incision shortly before CABG. Remote ischemic postconditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation) will be administered to the patient within 60 minutes after the completion of all coronary artery bypass grafts and the restoration of coronary blood flow. |
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| Control Group | Sham Comparator | Control group will receive sham procedure near identical to intervention. That will be afforded by inflation of pressure cuff on artificial leg hidden under the draping by an assistant who is not included in the research team and does not have any connection to study design and data analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning with Postconditioning | Procedure | Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative myocardial necrosis | Serial mesurements of High - Sensitive Troponin T release | 72 hours postoperatively |
| Postoperative kidney injury | Serial measurements of estimated glomerular filtration rate by creatinine | 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative mortality | 30-day all cause mortality | 30 days postoperatively |
| Perioperative myocardial infarction | 30-day myocardial infarction |
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Inclusion Criteria:
Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from:
Exclusion Criteria:
Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub S. Marczak, M.D. | Contact | 0048883774566 | marczak@space.pl | |
| Sleiman S. Aboul - Hassan, M.D. | Contact | 0048683882194 | s.aboulhassan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jakub S. Marczak, M.D. | Medinet Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medinet Heart Centre | Recruiting | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22286602 | Background | Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Sham RIPC procedure | Procedure | Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively. |
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| 30 days postoperatively |
| Postoperative Acute Kidney Injury | Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes. | 30 days |