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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Injury
 Procedure: RIPC
Procedure: Control
Drug: isoflurane+sufentanil anesthesia
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: July 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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)
Placebo Comparator: Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
 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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406678

Contacts
Contact: Matthias Thielmann, MD, PhD +49-723-84908 matthias.thielmann@uni-due.de

Locations
Germany
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen Recruiting
Essen, Germany, 45122
Contact: Matthias Thielmann, MD, PhD     +49-201-723-84908     matthias.thielmann@uni-due.de    
Principal Investigator: Matthias Thielmann, MD., PhD.            
Sponsors and Collaborators
University Hospital, Essen
Investigators
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Matthias Thielmann, Matthias Thielman, MD, PhD, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01406678     History of Changes
Other Study ID Numbers: WDHZ-TC-0801
Study First Received: December 1, 2009
Last Updated: April 25, 2013
Health Authority: Germany: Institutional Review Board, University of Duisburg-Essen

Keywords provided by University Hospital, Essen:
remote ischemic preconditioning
coronary artery bypass grafting
myocardial injury

Additional relevant MeSH terms:
Anesthetics
Isoflurane
Sufentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
 Anesthetics, General
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on June 18, 2013