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

Noncardiac Surgery Clinical Trial

— PREVENGE-CB-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812248
• Other study ID #: NFEC-2022-223
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: May 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Bingcheng Zhao, MD
• Phone: 86-13763313653
• Email: zhaobch[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

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.

Related Conditions & MeSH terms

• Noncardiac Surgery

Intervention

Diagnostic Test:
• Perioperative 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

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with major adverse cardiac event	A composite outcome that includes cardiac death, myocardial infarction, non-fatal cardiac arrest, and coronary revascularisation.	Within 30 days after the index surgery
Secondary	Number of patients with myocardial injury after noncardiac suregry (MINS)	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.	Within 30 days after the index surgery