About this trial
This observational study includes patients at medium-to-high cardiovascular risks undergoing major noncardiac surgery, measures their baseline demographic and clinical characteristics, preoperative cardiac biomarkers and intraoperative surgery/anesthesia related data, and screens them for the occurrence of myocardial injury and major adverse cardiac events after surgery. The primary aim is to develop and validate a pre- and an immediate postoperative prediction model for occurrence of major adverse cardiac events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 45 years;
Undergoing major noncardiac surgery (expected procedure duration ≥2 h, expected length of postoperative stay ≥2 d);
History of at least one cardiovascular disease (i.e., coronary artery disease, stroke, congestive heart failure, or peripheral arterial disease) or with at least two cardiovascular risk factors (i.e., hypertension, diabetes, chronic kidney disease, smoking in the past ≥2 years, ≥65 years of age, hypercholesterolemia, history of TIA, high-risk surgery (intrathoracic, intraperitoneal, or major vascular)).
Disqualifiers
History of acute cardiovascular events within 30 days prior to surgery;
American Society of Anesthesiologists (ASA) physical status of 5 or greater;
Previously enrolled in this study;
Unable to understand or to sign informed consent.
Trial population
Patients undergoing major noncardiac suregry with medium-to-high risks for postoperative cardiac complications.
Trial design
Cohort
Prospective
Treatments tested in this trial
Perioperative cardiac biomarker measurement
Diagnostic testHigh-sensitivity cardiac troponin T is measured within 7 days prior to surgery and at day 1 and day 2 after surgery. N-terminal pro-B-type natriuretic peptide is measured within 7 days before surgery.
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with major adverse cardiac event
A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.
Secondary outcomes
Number of patients with myocardial injury after noncardiac suregry (MINS)
MINS is defined as a postoperative hsTnT level of 20 to less than 65 ng/L with an absolute change of at least 5 ng/L or a postoperative hsTnT level of at least 65 ng/L. A 20% or greater increase of hsTnT level from preoperative baseline is required to exclude chronic troponin elevation. Troponin elevations believed to be consequent to nonischemic causes are excluded.
Sponsors and contacts
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