NCT05812248 Prediction of Vascular Events After Major Non-Cardiac Surgery : an Observational Prospective Cohort Study
| NCT ID | NCT05812248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Noncardiac Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-11 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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.