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| Name | Class |
|---|---|
| University Hospital, Essen | OTHER |
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Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.
Remote ischemic preconditioning (RIPC) protocol before CABG (study arm A) or OPCAB (study arm B) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest (A) or first coronary incision (B), and 5 to 10 minutes after aortic unclamping during reperfusion of the myocardium (A) or 5 to 10 minutes after the completion of the last anastomosis (B). Blood samples are taken prior to RIPC and during the first three postoperative days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC-CABG | Active Comparator | Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery with blood cardioplegia for cardiac arrest (CABG) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 to 10 Minutes after aortic unclamping during reperfusion of the myocardium. Blood samples are taken up to 72 hours postoperatively. |
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| Control-CABG | Placebo Comparator | Control group: Coronary artery bypass grafting without RIPC protocol |
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| RIPC-OPCAB | Active Comparator | Remote ischemic preconditioning (RIPC) protocol before Off-pump coronary artery bypass surgery (OPCAB) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before first coronary artery incision and 5 to 10 Minutes after completion of the coronary anastomoses. Blood samples are taken up to 72 hours postoperatively. |
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| Control-OPCAB | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning (RIPC) | Procedure | 3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion. The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC). | 72 hours postoperatively after CABG surgery |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days and 1 year after coronary bypass surgery | |
| Major adverse cardiac and cerebrovascular events (MACCE) | 30 days and 1 year after coronary bypass surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Payam Akhyari, MD | Contact | +492118118331 | payam.akhyari@med.uni-duesseldorf.de | |
| Artur Lichtenberg, MD | Contact | +492118118331 | artur.lichtenberg@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Payam Akhyari, MD | Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany | Principal Investigator |
| Alexander Albert, MD | Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University | Recruiting | Düsseldorf | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23334258 | Background | Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19. | |
| 22116817 |
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Control group: Off-pump Coronary artery bypass surgery without RIPC protocol
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| Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol | Procedure | The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations. |
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| Off-pump Coronary artery bypass surgery without remote ischemic preconditioning | Procedure | The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. |
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| Myocardial infarction |
| 30 days and 1 year after coronary bypass surgery |
| Renal function | 30 days and 1 year after coronary bypass surgery |
| circulating microparticles after coronary bypass surgery | perioperatively, 3 months and 1 year after coronary bypass surgery |
| Principal Investigator |
| Artur Lichtenberg, MD | Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany | Principal Investigator |
| Gerd Heusch, MD, PhD | nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany | Principal Investigator |
| Background |
| Heusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23. |
| ID | Term |
|---|---|
| D007530 | Isoflurane |
| D017409 | Sufentanil |
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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