RecruitingNCT05812248

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

20,000 participants

Start Date

Jul 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DIAGNOSTIC_TESTPerioperative cardiac biomarker measurement

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.


Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT05812248


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