Predicting heart events after major non-cardiac surgery

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

This study is trying to see if collecting certain health information before and during major surgeries can help predict heart problems in older patients who are at risk.

Quick facts

• Study type: Observational
• Enrollment: 20000 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05812248 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients aged 45 and older who are at medium-to-high cardiovascular risk and are undergoing major noncardiac surgery. It collects baseline demographic and clinical data, preoperative cardiac biomarkers, and intraoperative information to monitor for myocardial injury and major adverse cardiac events post-surgery. The primary goal is to develop and validate a prediction model for these cardiac events, enhancing preoperative risk assessment and patient management.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 and older with a history of cardiovascular disease or multiple cardiovascular risk factors undergoing major noncardiac surgery.

Not a fit: Patients with recent acute cardiovascular events or those with severe physical status (ASA 5 or greater) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the prediction and management of cardiac events in patients undergoing major non-cardiac surgeries.

How similar studies have performed: While there have been studies on cardiac event prediction in surgical patients, this specific approach focusing on a comprehensive preoperative model in a non-cardiac surgery context is relatively novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Bingcheng Zhao, MD

Conditions Noncardiac Surgery