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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
600
Nouvel Hopital Civil
Strasbourg, Bas Rhin, France
CHU Nord
Marseille, Bouches du Rhône, France
Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
Caen, Calvados, France
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)
Time frame: 3 Postoperative Days
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)
Time frame: 3 Postoperative days
Number of Participants With Myocardial Infarction (MI)
Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Time frame: 3 Postoperative Days
Number of Participants With Cerebro-Vascular Event
Patients with Cerebro-Vascular Event in the FAS
Time frame: 3 postoperative days
Number of Participants With Life-Threatening Arrhythmia
Patients with Life-Threatening Arrhythmia in the FAS
Time frame: 3 Postoperative Days
Number of Participants Who Died From Cardiac Origin
No patient died from a cardiac cause during the 3 postoperative days.
Time frame: 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
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CHU Dijon
Dijon, Côte d'Or, France
Hopital Pellegrin
Bordeaux, Gironde, France
CHU Bordeaux Haut Lévèque
Bordeaux, Gironde, France
CHU Rennes
Rennes, Ille et Vilaine, France
CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
Lille, Nord, France
Chu Pitie Salpetriere
Paris, Paris, France
Hopital Saint Joseph
Paris, Paris, France
...and 3 more locations
Time frame: 3 postoperative days
Systolic Blood Pressure (SBP)
Repeated Systolic Blood Pressure measurements during the perioperative period
Time frame: 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)
Time frame: From pre-induction to Postoperative Day 3
Vital Signs (Heart Rate Changes)
Changes from baseline for Heart Rate (HR)
Time frame: 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
Time frame: From Day 0 until Postoperative Day 3
Urine Output
Urine volume in milliliter (mL) during the first postoperative hours
Time frame: From Day 0 until Postoperative Day 1