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Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery (CARVASAXe)

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ClinicalTrials.gov Identifier: NCT01120405
Recruitment Status : Completed
First Posted : May 11, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborators:
Eurofins Biomnis
MONITORING FORCE GROUP CROs
INFERENTIAL
Information provided by (Responsible Party):
Air Liquide Santé International

Tracking Information
First Submitted Date  ICMJE May 4, 2010
First Posted Date  ICMJE May 11, 2010
Results First Submitted Date  ICMJE March 20, 2014
Results First Posted Date  ICMJE June 17, 2014
Last Update Posted Date June 17, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Number of Participants With Myocardial Necrosis (MN) [ Time Frame: 3 Postoperative Days ]
Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2010)
positive cTnI ultra sensitive assay (above the 99th percentile), at any time during the 72 h post operatively [ Time Frame: postop up to 3 days ]
The primary efficacy criterion is a biological marker:Increase above the 99th percentile of highly sensitive cTnI (threshold established by the producer- central laboratory) at any time during the 72 h post operatively. Evaluations will be performed before surgery, 60±15 minutes after end of GA, in the morning of D1 and D3 following surgery and at any other time in case of suspicion of Myocardial necrosis (damage). Increase above the 99th percentile of highly sensitive cTnI will define Myocardial Necrosis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories) [ Time Frame: 3 Postoperative days ]
    At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
  • Number of Participants With Myocardial Infarction (MI) [ Time Frame: 3 Postoperative Days ]
    Patients with Confirmed Myocardial Infarction (MI) by the Investigators
  • Number of Participants With Cerebro-Vascular Event [ Time Frame: 3 postoperative days ]
    Patients with Cerebro-Vascular Event in the FAS
  • Number of Participants With Life-Threatening Arrhythmia [ Time Frame: 3 Postoperative Days ]
    Patients with Life-Threatening Arrhythmia in the FAS
  • Number of Participants Who Died From Cardiac Origin [ Time Frame: 3 postoperative days ]
    No patient died from a cardiac cause during the 3 postoperative days.
  • Number of Participants With Composite Endpoint [ Time Frame: 3 postoperative days ]
    Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
  • Systolic Blood Pressure (SBP) [ Time Frame: From pre-induction to recovery of anesthesia ]
    Repeated Systolic Blood Pressure measurements during the perioperative period
  • Vital Signs (SBP and DBP Changes) [ Time Frame: From pre-induction to Postoperative Day 3 ]
    Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
  • Vital Signs (Heart Rate Changes) [ Time Frame: From pre-induction to Postoperative Day 3 ]
    Changes from baseline for Heart Rate (HR)
  • Number of Participants With Chest Pain During the 3 Postoperative Days [ Time Frame: From Day 0 until Postoperative Day 3 ]
    Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
  • Urine Output [ Time Frame: From Day 0 until Postoperative Day 1 ]
    Urine volume in milliliter (mL) during the first postoperative hours
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2010)
Routine post operative cardiac safety [ Time Frame: Post operatively up to 3 days ]
Routine (Local laboratory) dosage of standard cTnI at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction, Routine post op cardiac safety monitoring from the D0 to D3(Blood pressure , 12-lead ECG recording, Chest pain , Heart rate ), 24h diuresis, Diagnosis of MI, Diagnosis of the composite endpoint including MI, MN, cerebrovascular events, life threatening arrhythmia, and death from cardiac origin
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Official Title  ICMJE Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
Brief Summary The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
Detailed Description

The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;

Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE
  • Elevated Cardiac Risk
  • Coronary Arteries Disease Risk
Intervention  ICMJE
  • Drug: Xenon
    Other Name: LENOXe
  • Drug: Sevoflurane
    Other Name: Sevo
Study Arms  ICMJE
  • Experimental: Xenon
    0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
    Intervention: Drug: Xenon
  • Active Comparator: sevoflurane
    0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
    Intervention: Drug: Sevoflurane
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
600
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2010)
560
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
  • Cardiac ischaemic risk supported by:

    • History of myocardial infarction older than 1 month and/or
    • Documented Stable angina (asymptomatic ± medical treatment) and/or
    • History of coronary revascularisation, and/or
    • Surgical Risk Index ("Lee" index) ≥ 3.
    • Written informed consent

Exclusion Criteria:

  • Unstable angina within the last 30 days,
  • Non controlled arterial Hypertension .
  • Severe Cardiac heart Failure (NYHA IV)
  • Severe Chronic Obstructive Pulmonary Disease
  • Patient already randomized in another ongoing clinical trial
  • Patient with recent myocardial infarction (M.I) (less than one month )
  • Patient already included in a clinical trial
  • History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
  • Malignant hyperthermia
  • Documented Elevated intracranial pressure
  • Preeclampsia or eclampsia
  • Pregnancy and lactation
  • Presumed uncooperativeness or legal incapacity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01120405
Other Study ID Numbers  ICMJE EudraCT #2010-018703-28
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Air Liquide Santé International
Study Sponsor  ICMJE Air Liquide Santé International
Collaborators  ICMJE
  • Eurofins Biomnis
  • MONITORING FORCE GROUP CROs
  • INFERENTIAL
Investigators  ICMJE
Principal Investigator: Yanncik Le Manach, MD CHU PITIE SALPETRIERE, PARIS, FRANCE
Study Chair: Pierre CORIAT, MD Prof CHU PITIE SALPETRIERE, PARIS, FRANCE
Study Chair: Benoit VALLET, MD Prof University Hospital, Lille
PRS Account Air Liquide Santé International
Verification Date May 2014

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