Coronary Arteries Disease Risk Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening