Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Essen
Sponsor:
Information provided by (Responsible Party):
Matthias Thielmann, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01406678
First received: December 1, 2009
Last updated: April 25, 2013
Last verified: April 2013

December 1, 2009
April 25, 2013
July 2008
October 2012   (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 CABG 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 NCT01406678 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: 30 days and 1 year and complete follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: at 30 days and 1 year and complete follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 30 days and 1 year and complete follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: 72 hours post CABG ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 30 days and 1 year follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: at 30 days and 1 year follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 30 days and 1 year follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
  • Renal function [ Time Frame: 30 days and 1 year follow-up after CABG surgery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest
Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.

Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision 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. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Injury
  • Procedure: RIPC
    3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
    Other Names:
    • RIPC: Remote ischemic preconditioning
    • CABG: Coronary artery bypass grafting
  • Procedure: Control
    Coronary artery bypass surgery without remote ischemic preconditioning protocol
    Other Name: Coronary artery bypass surgery
  • Drug: 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.
    Other Names:
    • Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane
    • Sufentanil, Sufenta, (R-30730)
  • Active Comparator: RIPC
    Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery 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 and 10 Minutes after aortic unclamping during reperfusion of the myocardium.
    Interventions:
    • Procedure: RIPC
    • Drug: isoflurane+sufentanil anesthesia
  • Placebo Comparator: Control
    Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
    Interventions:
    • Procedure: Control
    • Drug: isoflurane+sufentanil anesthesia

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2015
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Consecutive patients >18 years of age
  • Double- or triple-vessel coronary artery disease
  • Elective isolated first-time CABG
  • Combined valve surgery + CABG
  • Written informed consent

Exclusion Criteria:

  • Renal failure (creatinine ≥ 200 µmol/L)
  • Peripheral vascular disease affecting upper limbs
  • Preoperative inotropic support
  • Any kind of mechanical assist device
  • Acute or recent (<4 weeks) acute coronary syndromes
  • Any PCI (<6 weeks)
  • Any reasons for preoperative cTnI elevation
  • Emergency surgery
  • Redo surgery
Both
18 Years and older
No
Contact: Matthias Thielmann, MD, PhD +49-723-84908 matthias.thielmann@uni-due.de
Germany
 
NCT01406678
WDHZ-TC-0801
Yes
Matthias Thielmann, University Hospital, Essen
University Hospital, Essen
Not Provided
Principal Investigator: Matthias Thielmann, MD, PhD Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen, Essen, Germany
Principal Investigator: Eva Kottenberg, M.D., PhD. Klinik für Anästhesiologie und Intensivmedizin, Universität Duisburg-Essen, Universitätsklinikum Essen, Essen, Germany
Principal Investigator: Gerd Heusch, M.D., PhD. Institut für Pathophysiologie, Universität Duisburg-Essen, Universitätsklinikum Essen, Essen, Germany
University Hospital, Essen
April 2013

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