Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
RIPCON
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 16, 2013
July 1, 2013
3.1 years
May 29, 2012
July 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (4)
RIPC-CABG
ACTIVE COMPARATORRemote 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.
Control-CABG
PLACEBO COMPARATORControl group: Coronary artery bypass grafting without RIPC protocol
RIPC-OPCAB
ACTIVE COMPARATORRemote 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
PLACEBO COMPARATORControl group: Off-pump Coronary artery bypass surgery without RIPC protocol
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Confirmed triple vessel coronary artery disease
- Indication for surgical coronary revascularisation
- Written informed consent
- Age ≥ 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heinrich-Heine University, Duesseldorflead
- University Hospital, Essencollaborator
Study Sites (1)
Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University
Düsseldorf, 40225, Germany
Related Publications (2)
Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19.
PMID: 23334258BACKGROUNDHeusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23.
PMID: 22116817BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2012
First Posted
May 31, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
July 16, 2013
Record last verified: 2013-07