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

Primary Purpose

Myocardial Injury

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning (RIPC)
Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol
Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Injury focused on measuring remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

RIPC-CABG

Control-CABG

RIPC-OPCAB

Control-OPCAB

Arm 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.

Control group: Coronary artery bypass grafting without RIPC protocol

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

All-cause mortality
Major adverse cardiac and cerebrovascular events (MACCE)
Myocardial infarction
Renal function
circulating microparticles after coronary bypass surgery

Full Information

First Posted
May 29, 2012
Last Updated
July 15, 2013
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01608984
Brief Title
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
Acronym
RIPCON
Official Title
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
University Hospital, Essen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Injury
Keywords
remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC-CABG
Arm Type
Active Comparator
Arm 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.
Arm Title
Control-CABG
Arm Type
Placebo Comparator
Arm Description
Control group: Coronary artery bypass grafting without RIPC protocol
Arm Title
RIPC-OPCAB
Arm Type
Active Comparator
Arm 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.
Arm Title
Control-OPCAB
Arm Type
Placebo Comparator
Arm Description
Control group: Off-pump Coronary artery bypass surgery without RIPC protocol
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning (RIPC)
Other Intervention Name(s)
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)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Time Frame
72 hours postoperatively after CABG surgery
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days and 1 year after coronary bypass surgery
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame
30 days and 1 year after coronary bypass surgery
Title
Myocardial infarction
Time Frame
30 days and 1 year after coronary bypass surgery
Title
Renal function
Time Frame
30 days and 1 year after coronary bypass surgery
Title
circulating microparticles after coronary bypass surgery
Time Frame
perioperatively, 3 months and 1 year after coronary bypass surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Payam Akhyari, MD
Phone
+492118118331
Email
payam.akhyari@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name or Official Title & Degree
Artur Lichtenberg, MD
Phone
+492118118331
Email
artur.lichtenberg@med.uni-duesseldorf.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, MD
Organizational Affiliation
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Albert, MD
Organizational Affiliation
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Artur Lichtenberg, MD
Organizational Affiliation
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerd Heusch, MD, PhD
Organizational Affiliation
nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, MD
Phone
+492118118331
Email
payam.akhyari@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Alexander Albert, MD
Phone
+492118118331
Email
alexander.albert@med.uni-duesseldorf.de
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, MD
First Name & Middle Initial & Last Name & Degree
Alexander Albert, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23334258
Citation
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.
Results Reference
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PubMed Identifier
22116817
Citation
Heusch 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.
Results Reference
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Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)

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