Myocardial Injury
Conditions
Keywords
remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERemote ischemic preconditioning (RIPC)
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.
PROCEDURECoronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol
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.
PROCEDUREOff-pump Coronary artery bypass surgery without remote ischemic preconditioning
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.
Sponsors
University Hospital, Essen
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed triple vessel coronary artery disease * Indication for surgical coronary revascularisation * Written informed consent * Age ≥ 18 years
Exclusion criteria
* Age \> 80 years * Instable angina/acute coronary syndrome * Emergency surgery * Recent myocardial infarction within 7 days prior to surgery * Recent major infection/sepsis within 7 days prior to surgery * Significant hepatic, renal oder pulmonary disease * Other concomitant surgical procedures
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactPayam Akhyari, MD
Backup ContactArtur Lichtenberg, MD
Outcome results
None listed