Myocardial Injury
Conditions
Keywords
remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury
Brief summary
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.
Detailed description
Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision 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. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.
Interventions
PROCEDURERIPC
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
PROCEDUREControl
Coronary artery bypass surgery without remote ischemic preconditioning protocol
DRUGisoflurane+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.
Sponsors
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients \>18 years of age * Double- or triple-vessel coronary artery disease * Elective isolated first-time CABG * Combined valve surgery + CABG * Written informed consent
Exclusion criteria
* Renal failure (creatinine ≥ 200 µmol/L) * Peripheral vascular disease affecting upper limbs * Preoperative inotropic support * Any kind of mechanical assist device * Acute or recent (\<4 weeks) acute coronary syndromes * Any PCI (\<6 weeks) * Any reasons for preoperative cTnI elevation * Emergency surgery * Redo surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG 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 and complete follow-up after CABG surgery |
| Major adverse cardiac and cerebrovascular events (MACCE) | at 30 days and 1 year and complete follow-up after CABG surgery |
| Myocardial infarction | 30 days and 1 year and complete follow-up after CABG surgery |
| Renal function | 72 hours post CABG |
Countries
Germany
Outcome results
None listed