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

Phase 1
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
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
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
All-cause mortality30 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 infarction30 days and 1 year after coronary bypass surgery
Renal function30 days and 1 year after coronary bypass surgery
circulating microparticles after coronary bypass surgeryperioperatively, 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, Germany
Payam Akhyari, MD
Principal Investigator
Alexander Albert, MD
Principal Investigator

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