A Phase 2/3 interventional study of RIPC and Control in Myocardial Injury, sponsored by University Hospital, Essen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University Hospital, Essen · Phase 2/3, Interventional, and Treatment
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.
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.
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's enrollment of 1,204 is above the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.
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Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery 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 and 10 Minutes after aortic unclamping during reperfusion of the myocardium.
Procedure: RIPC · Drug: isoflurane+sufentanil anesthesia
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
Procedure: Control · Drug: isoflurane+sufentanil anesthesia
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
Also known as: RIPC: Remote ischemic preconditioning, CABG: Coronary artery bypass grafting
Coronary artery bypass surgery without remote ischemic preconditioning protocol
Also known as: Coronary artery bypass surgery
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.
Also known as: Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane, Sufentanil, Sufenta, (R-30730)
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).
Time frame: 72 hours postoperatively after CABG surgery
All-cause mortality
Time frame: 30 days and 1 year and complete follow-up after CABG surgery
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: at 30 days and 1 year and complete follow-up after CABG surgery
Myocardial infarction
Time frame: 30 days and 1 year and complete follow-up after CABG surgery
Renal function
Time frame: 72 hours post CABG
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Essen