Elevated Cardiac RiskPhase 3CARVASAXeNCT01120405
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
A Phase 3 study testing Xenon and Sevoflurane in people with Elevated Cardiac Risk and Coronary Arteries Disease Risk, run by Air Liquide Santé International at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Cardiac Risk, Coronary Arteries Disease Risk
- What is being tested?
- Xenon and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 13 sitesFrance
- Study dates
- May 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 )
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Hopital Pellegrin
Bordeaux, Gironde, 33076
CHU Bordeaux Haut Lévèque
Bordeaux, Gironde, 33604
Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
Caen, Calvados, 14033 Cedex 9
CHU Clermont Ferrand
Clermont-Ferrand, Puy de Dôme, 63003
Hopital Henri Mondor
Créteil, Val de Marne, 94000
CHU Dijon
Dijon, Côte d'Or, 21079
CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
Lille, Nord, 59037 Cedex
CHU Nord
Marseille, Bouches du Rhône, 13915
Chu Pitie Salpetriere
Paris, Paris, 75013
Hopital Saint Joseph
Paris, Paris, 75014
CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
Poitiers, Vienne, 86021 Cedex
CHU Rennes
Rennes, Ille et Vilaine, 35009
Nouvel Hopital Civil
Strasbourg, Bas Rhin, 67091
About this study
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
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.
Read the 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.
- Being tested
- Xenon, Sevoflurane
- Keywords
- Xenon, Cardiac safety, Cardiovascular risk, Non cardiac surgery, Atherosclerotic vascular surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called LENOXe
SevofluraneDrug
Also called Sevo
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A) Receives: Drug: Xenon |
| sevoflurane | Active comparator | 0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B) Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 Postoperative Days
Secondary outcomes (11)
Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
Measured: 3 Postoperative days
Number of Participants With Myocardial Infarction (MI)
Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Measured: 3 Postoperative Days
Number of Participants With Cerebro-Vascular Event
Patients with Cerebro-Vascular Event in the FAS
Measured: 3 postoperative days
Number of Participants With Life-Threatening Arrhythmia
Patients with Life-Threatening Arrhythmia in the FAS
Measured: 3 Postoperative Days
Number of Participants Who Died From Cardiac Origin
No patient died from a cardiac cause during the 3 postoperative days.
Measured: 3 postoperative days
Number of Participants With Composite Endpoint
Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
Measured: 3 postoperative days
Systolic Blood Pressure (SBP)
Repeated Systolic Blood Pressure measurements during the perioperative period
Measured: From pre-induction to recovery of anesthesia
Vital Signs (SBP and DBP Changes)
Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Measured: From pre-induction to Postoperative Day 3
Vital Signs (Heart Rate Changes)
Changes from baseline for Heart Rate (HR)
Measured: From pre-induction to Postoperative Day 3
Number of Participants With Chest Pain During the 3 Postoperative Days
Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
Measured: From Day 0 until Postoperative Day 3
Urine Output
Urine volume in milliliter (mL) during the first postoperative hours
Measured: From Day 0 until Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elevated Cardiac RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Biomnis, Monitoring Force Group, Inferential
- Responsible party
- Sponsor
- Investigators
- Yanncik Le Manach, MD, Principal investigator, CHU PITIE SALPETRIERE, PARIS, FRANCEPierre CORIAT, MD Prof, Study chair, CHU PITIE SALPETRIERE, PARIS, FRANCEBenoit VALLET, MD Prof, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120405
- Sponsor's protocol ID
- EudraCT #2010-018703-28
- Acronym
- CARVASAXe
- Status last verified
- May 2014
- First submitted
- 4 May 2010
- Last updated
- 17 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01120405
- Acronym / sponsor ID
- CARVASAXe / EudraCT #2010-018703-28
- Keywords
- Xenon, Cardiac safety, Cardiovascular risk, Non cardiac surgery, Atherosclerotic vascular surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Biomnis, Monitoring Force Group, Inferential
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 17 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: Xenon0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A) |
| sevoflurane | Active comparator | Drug: Sevoflurane0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
- Cardiac ischaemic risk supported by:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonAlso: LENOXe | Drug | Xenon |
| SevofluraneAlso: Sevo | Drug | sevoflurane |
Primary outcome
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)
11 secondary outcomes
Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
Time frame: 3 Postoperative days
Number of Participants With Myocardial Infarction (MI)
Time frame: 3 Postoperative Days
Number of Participants With Cerebro-Vascular Event
Time frame: 3 postoperative days
Number of Participants With Life-Threatening Arrhythmia
Time frame: 3 Postoperative Days
Number of Participants Who Died From Cardiac Origin
Time frame: 3 postoperative days
Number of Participants With Composite Endpoint
Time frame: 3 postoperative days
Systolic Blood Pressure (SBP)
Time frame: From pre-induction to recovery of anesthesia
Vital Signs (SBP and DBP Changes)
Time frame: From pre-induction to Postoperative Day 3
Vital Signs (Heart Rate Changes)
Time frame: From pre-induction to Postoperative Day 3
Number of Participants With Chest Pain During the 3 Postoperative Days
Time frame: From Day 0 until Postoperative Day 3
Urine Output
Time frame: From Day 0 until Postoperative Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanncik Le Manach, MD principal investigator
CHU PITIE SALPETRIERE, PARIS, FRANCE
Pierre CORIAT, MD Prof study chair
CHU PITIE SALPETRIERE, PARIS, FRANCE
Benoit VALLET, MD Prof study chair
University Hospital, Lille
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon and Sevoflurane in people with Elevated Cardiac Risk and Coronary Arteries Disease Risk, run by Air Liquide Santé International at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Myocardial Necrosis (MN) (time frame: 3 Postoperative Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.