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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120405
First Posted: May 11, 2010
Last Update Posted: June 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
INFERENTIAL
Information provided by (Responsible Party):
Air Liquide Santé International
  Purpose
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.

Condition Intervention Phase
Elevated Cardiac Risk Coronary Arteries Disease Risk Drug: Xenon Drug: Sevoflurane Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 600
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenon
0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
Drug: Xenon
Other Name: LENOXe
Active Comparator: sevoflurane
0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
Drug: Sevoflurane
Other Name: Sevo

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01120405


Locations
France
Nouvel Hopital Civil
Strasbourg, Bas Rhin, France, 67091
CHU Nord
Marseille, Bouches du Rhône, France, 13915
Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
Caen, Calvados, France, 14033 Cedex 9
CHU Dijon
Dijon, Côte d'Or, France, 21079
Hopital Pellegrin
Bordeaux, Gironde, France, 33076
CHU Bordeaux Haut Lévèque
Bordeaux, Gironde, France, 33604
CHU Rennes
Rennes, Ille et Vilaine, France, 35009
CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
Lille, Nord, France, 59037 Cedex
CHU Clermont Ferrand
Clermont Ferrand, Puy de Dôme, France, 63003
Hopital Henri Mondor
Creteil, Val de Marne, France, 94000
CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
Poitiers, Vienne, France, 86021 Cedex
Chu Pitie Salpetriere
Paris, France, 75013
Hopital Saint Joseph
Paris, France, 75014
Sponsors and Collaborators
Air Liquide Santé International
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
INFERENTIAL
Investigators
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
  More Information

Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01120405     History of Changes
Other Study ID Numbers: EudraCT #2010-018703-28
First Submitted: May 4, 2010
First Posted: May 11, 2010
Results First Submitted: March 20, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014

Keywords provided by Air Liquide Santé International:
Xenon
Cardiac safety
Cardiovascular risk
Non cardiac surgery
Atherosclerotic vascular surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sevoflurane
Xenon
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs