Coronary Arteries Disease Risk Clinical Trial
— CARVASAXeOfficial 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.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Bordeaux Haut Lévèque | Bordeaux | Gironde |
| France | Hopital Pellegrin | Bordeaux | Gironde |
| France | Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre | Caen | Calvados |
| France | CHU Clermont Ferrand | Clermont Ferrand | Puy de Dôme |
| France | Hopital Henri Mondor | Creteil | Val de Marne |
| France | CHU Dijon | Dijon | Côte d'Or |
| France | CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc | Lille | Nord |
| France | CHU Nord | Marseille | Bouches du Rhône |
| France | Chu Pitie Salpetriere | Paris | |
| France | Hopital Saint Joseph | Paris | |
| France | CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577 | Poitiers | Vienne |
| France | CHU Rennes | Rennes | Ille et Vilaine |
| France | Nouvel Hopital Civil | Strasbourg | Bas Rhin |
| Lead Sponsor | Collaborator |
|---|---|
| Air Liquide Santé International | BIOMNIS Central laboratory, INFERENTIAL, MONITORING FORCE GROUP CROs |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) | 3 Postoperative days | No |
| Secondary | Number of Participants With Myocardial Infarction (MI) | Patients with Confirmed Myocardial Infarction (MI) by the Investigators | 3 Postoperative Days | No |
| Secondary | Number of Participants With Cerebro-Vascular Event | Patients with Cerebro-Vascular Event in the FAS | 3 postoperative days | No |
| Secondary | Number of Participants With Life-Threatening Arrhythmia | Patients with Life-Threatening Arrhythmia in the FAS | 3 Postoperative Days | No |
| Secondary | Number of Participants Who Died From Cardiac Origin | No patient died from a cardiac cause during the 3 postoperative days. | 3 postoperative days | No |
| Secondary | 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 | 3 postoperative days | No |
| Secondary | Systolic Blood Pressure (SBP) | Repeated Systolic Blood Pressure measurements during the perioperative period | From pre-induction to recovery of anesthesia | No |
| Secondary | Vital Signs (SBP and DBP Changes) | Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP) | From pre-induction to Postoperative Day 3 | Yes |
| Secondary | Vital Signs (Heart Rate Changes) | Changes from baseline for Heart Rate (HR) | From pre-induction to Postoperative Day 3 | Yes |
| Secondary | 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 | From Day 0 until Postoperative Day 3 | Yes |
| Secondary | Urine Output | Urine volume in milliliter (mL) during the first postoperative hours | From Day 0 until Postoperative Day 1 | Yes |