Status
Recruiting
Phase
Not applicable
Enrollment
20,000
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DIAGNOSTIC_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.
Timeline
First posted
Apr 13, 2023
Study start
Jul 1, 2022
Primary completion
Nov 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Sep 19, 2024
Outcomes
Number of patients with major adverse cardiac event
Time frame · Within 30 days after the index surgery
A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.
Number of patients with myocardial injury after noncardiac suregry (MINS)
Time frame · Within 30 days after the index surgery
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.
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Publications
No PMID-linked publications were present in this registry snapshot.
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