About this trial
This observational study includes patients undergoing major non-cardiac surgery, and screens them for the occurrence of perioperative myocardial injuries (PMI). Incidence, patient characteristics, pathophysiology, potential prevention and therapy strategies and 1-year outcomes of PMI will be described.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients received a perioperative hs-cTnT screening for PMI
Patient consent available
Disqualifiers
Patient's refusal
Trial population
Consecutive patients that underwent a systematic approach to PMI detection at the participating hospitals as clinical routine will be included. The screening consists of a pre-operative "baseline" measurement of hs-cTnT within 30 days prior to surgery, and two post-operative measurements taken on the first and second day after surgery. Screening is done in patients requiring hospitalization \>24 hours after surgery AND (aged ≥ 65 years OR history of coronary artery disease OR peripheral artery occlusive disease OR cerebrovascular disease). Patients are seen by a cardiologist in case of detection of a PMI.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Deaths in one year after non-cardiac surgery in patients with and without PMI
Secondary outcomes
MACE in one year after non-cardiac surgery in patients with and without PMI
MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), or acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit) within one year. Two independent cardiologists or anaesthesiologists will adjudicate all MACE.
Incidence of PMI within a screening program in high-risk patients undergoing major non-cardiac surgery
PMI is defined as an absolute increase in h/s-cTn of the 99th percentile of healthy individuals for the respective assay above baseline cTn-value or between two postoperative values if the preoperative value was missing. PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes.
Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery
Patients with PMI are evaluated for: presence of chest pain, atypical symptoms, palpitations, dyspnea, edema, or nausea; ST-changes, Q-waves, T-wave abnormalities, new bundle branch block
Number of patients with PMI with management changes after screening-induced consultation
Changes in management can be: changes in medication, intensification of surveillance, call for use of coronary angiography, myocardial stress testing, other, or none
Other outcomes
Estimate potential effect of detection and management of PMI on major adverse cardiac events by a screening program implemented within clinical routine
Compare cardiac troponin T and I in the detection of PMI
Sponsors and contacts
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University Hospital, Basel, Switzerland
Lead sponsor
Cantonal Hospital of Aarau, Switzerland
Collaborator