Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)

Phase 1

• Conditions: Myocardial Injury
• Interventions: Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol; Procedure: Remote ischemic preconditioning (RIPC); Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning

• Registration Number: NCT01608984
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control-CABG	Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol	Control group: Coronary artery bypass grafting without RIPC protocol
RIPC-OPCAB	Remote ischemic preconditioning (RIPC)	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.
Control-OPCAB	Off-pump Coronary artery bypass surgery without remote ischemic preconditioning	Control group: Off-pump Coronary artery bypass surgery without RIPC protocol
RIPC-CABG	Remote ischemic preconditioning (RIPC)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University; 🇩🇪 Duesseldorf, Germany