Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest (RIPC-CCA)

This study is currently recruiting participants.

Verified December 2009 by University Hospital, Essen

Sponsor:

Information provided by:

University Hospital, Essen

ClinicalTrials.gov Identifier:

NCT01406678

First received: December 1, 2009

Last updated: August 3, 2011

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2009

Last Updated Date

August 3, 2011

Start Date ^ICMJE

July 2008

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest

Brief Summary

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 purpose of the present study is therefore to determine, whether or not RIPC is still operative when standard crystalloid cardioplegic arrest is used for myocardial protection.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Injury

Intervention ^ICMJE

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)
Drug: propofol+sufentanil
Anaesthesia is maintained by continuous propofol infusion (0.07 - 0.15 mg/kg/min), with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive continuous propofol infusion.

Other Name: propofol, diprivan, disoprivan, sufentanil, sufenta

Study Arm (s)

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
- Drug: propofol+sufentanil
Placebo Comparator: Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
Interventions:
- Procedure: Control
- Drug: isoflurane+sufentanil anesthesia
- Drug: propofol+sufentanil

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

July 2013

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Consecutive patients >18 years of age
Triple-vessel coronary artery disease
Non-diabetic
Elective isolated first-time CABG
Written informed consent

Exclusion Criteria:

Diabetes mellitus
Anti-diabetic medications
Renal failure (creatinine ≥ 200 µmol/L)
Peripheral vascular disease affecting upper limbs
Unstable angina
Preoperative inotropic support
Any kind of mechanical assist device
Acute or recent (<2 weeks) myocardial infarction
Any reasons for preoperative cTnI elevation
Emergency surgery
Combined surgery
Redo surgery

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Matthias Thielmann, MD, PhD

+49-723-84908

matthias.thielmann@uni-due.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01406678

Other Study ID Numbers ^ICMJE

WDHZ-TC-0801

Has Data Monitoring Committee

Yes

Responsible Party

Matthias Thielman, MD, PhD, Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Essen, Germany

Study Sponsor ^ICMJE

University Hospital, Essen

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University Hospital, Essen

Verification Date

December 2009

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

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