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

Recruiting

• Conditions: Noncardiac Surgery

• Registration Number: NCT05812248
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-02
• Study First Posted: 2023-04-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31
• Primary Completion: 2027-11
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with major adverse cardiac event	Within 30 days after the index surgery	A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.

Secondary Outcome Measures

Name	Time	Method
Number of patients with myocardial injury after noncardiac suregry (MINS)	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.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China