Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
CARVASAXe
1 other identifier
interventional
600
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
June 17, 2014
CompletedJune 17, 2014
May 1, 2014
2.2 years
May 4, 2010
March 20, 2014
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Myocardial Necrosis (MN)
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)
3 Postoperative Days
Secondary Outcomes (11)
Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
3 Postoperative days
Number of Participants With Myocardial Infarction (MI)
3 Postoperative Days
Number of Participants With Cerebro-Vascular Event
3 postoperative days
Number of Participants With Life-Threatening Arrhythmia
3 Postoperative Days
Number of Participants Who Died From Cardiac Origin
3 postoperative days
- +6 more secondary outcomes
Study Arms (2)
Xenon
EXPERIMENTAL0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
sevoflurane
ACTIVE COMPARATOR0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Air Liquide Santé Internationallead
- Eurofins Biomniscollaborator
- Monitoring Force Groupcollaborator
- Inferentialcollaborator
Study Sites (13)
Nouvel Hopital Civil
Strasbourg, Bas Rhin, 67091, France
CHU Nord
Marseille, Bouches du Rhône, 13915, France
Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
Caen, Calvados, 14033 Cedex 9, France
CHU Dijon
Dijon, Côte d'Or, 21079, France
Hopital Pellegrin
Bordeaux, Gironde, 33076, France
CHU Bordeaux Haut Lévèque
Bordeaux, Gironde, 33604, France
CHU Rennes
Rennes, Ille et Vilaine, 35009, France
CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
Lille, Nord, 59037 Cedex, France
Chu Pitie Salpetriere
Paris, Paris, 75013, France
Hopital Saint Joseph
Paris, Paris, 75014, France
CHU Clermont Ferrand
Clermont-Ferrand, Puy de Dôme, 63003, France
Hopital Henri Mondor
Créteil, Val de Marne, 94000, France
CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
Poitiers, Vienne, 86021 Cedex, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yannick LE MANACH, MD, PhD
- Organization
- Population Health Research Institute - Mc Master University, Hamilton CANADA
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 11, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 17, 2014
Results First Posted
June 17, 2014
Record last verified: 2014-05