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

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ClinicalTrials.gov Identifier: NCT01406678
Recruitment Status : Recruiting
First Posted : August 1, 2011
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Matthias Thielmann, University Hospital, Essen

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Injury Procedure: RIPC Procedure: Control Drug: isoflurane+sufentanil anesthesia Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : July 2008
Primary Completion Date : October 2012
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Isoflurane
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days and 1 year and complete follow-up after CABG surgery ]
  2. Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: at 30 days and 1 year and complete follow-up after CABG surgery ]
  3. Myocardial infarction [ Time Frame: 30 days and 1 year and complete follow-up after CABG surgery ]
  4. Renal function [ Time Frame: 72 hours post CABG ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

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

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