Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
- Conditions
- Myocardial Injury
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Confirmed triple vessel coronary artery disease
- Indication for surgical coronary revascularisation
- Written informed consent
- Age ≥ 18 years
- 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
- 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
Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University🇩🇪Duesseldorf, GermanyPayam Akhyari, MDPrincipal InvestigatorAlexander Albert, MDPrincipal Investigator