Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort Study

Nanfang Hospital, Southern Medical University20,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Noncardiac Surgery

Interventions

Perioperative cardiac biomarker measurementDIAGNOSTIC_TEST

High-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.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * 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)). Exclusion Criteria: * 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.

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.

Time frame: Within 30 days after the index surgery

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.