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

Heinrich-Heine University, Duesseldorf

Status and phase: Unknown; Phase 1

Conditions: Myocardial Injury

Treatments: Procedure: Remote ischemic preconditioning (RIPC); Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning; Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01608984

RIPCON-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

RIPC-CABG

Active Comparator group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning (RIPC)

Control-CABG

Placebo Comparator group

Description:

Control group: Coronary artery bypass grafting without RIPC protocol

Treatment:

Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol

RIPC-OPCAB

Active Comparator group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning (RIPC)

Control-OPCAB

Placebo Comparator group

Description:

Control group: Off-pump Coronary artery bypass surgery without RIPC protocol

Treatment:

Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning