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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Essen
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01608984
First received: May 29, 2012
Last updated: May 30, 2012
Last verified: May 2012
History of Changes

May 29, 2012
May 30, 2012
May 2012
June 2013   (final data collection date for primary outcome measure)
Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC). [ Time Frame: 72 hours postoperatively after CABG surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01608984 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: 30 days and 1 year after coronary bypass surgery ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 30 days and 1 year after coronary bypass surgery ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 30 days and 1 year after coronary bypass surgery ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: 30 days and 1 year after coronary bypass surgery ] [ Designated as safety issue: Yes ]
  • circulating microparticles after coronary bypass surgery [ Time Frame: perioperatively, 3 months and 1 year after coronary bypass surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Injury
  • Procedure: Remote ischemic preconditioning (RIPC)

    3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion.

    The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

    Other Names:
    • RIPC: remote ischemic preconditioning
    • CABG: coronary artery bypass grafting
    • OPCAB: Off-pump coronary artery bypass surgery
    • Isoflurane: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, Forane
    • Sufentanil, Sufenta, (R-30730)
  • Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol
    The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia 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.
  • Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
    The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required.
  • Active Comparator: RIPC-CABG
    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.
    Intervention: Procedure: Remote ischemic preconditioning (RIPC)
  • Placebo Comparator: Control-CABG
    Control group: Coronary artery bypass grafting without RIPC protocol
    Intervention: Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol
  • Active Comparator: RIPC-OPCAB
    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.
    Intervention: Procedure: Remote ischemic preconditioning (RIPC)
  • Placebo Comparator: Control-OPCAB
    Control group: Off-pump Coronary artery bypass surgery without RIPC protocol
    Intervention: Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed triple vessel coronary artery disease
  • Indication for surgical coronary revascularisation
  • Written informed consent
  • Preserved left ventricular function (EF > 50%)
  • 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
  • Diabetes mellitus requiring medication
  • Other concomitant surgical procedures
  • Peripheral vascular disease
  • Anatomic conditions hindering the direct identification of the course of coronary vessels (excessive epicardial fat tissue or intramyocardial coronary)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01608984
RIPCON-12
Yes
Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
University Hospital, Essen
Principal Investigator: Payam Akhyari, MD Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Principal Investigator: Alexander Albert, MD Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Principal Investigator: Artur Lichtenberg, MD Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Principal Investigator: Gerd Heusch, MD, PhD nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
Heinrich-Heine University, Duesseldorf
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP