PREVENGE-CB-2: Prediction of Vascular Events After Major Non-Cardiac Surgery With Preoperative Cardiac Biomarkers-2

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05812248

Collaborator

(none)

20,000

Enrollment

Location

Anticipated Duration (Months)

307.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Noncardiac Surgery	Diagnostic Test: Perioperative cardiac biomarker measurement

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prediction of Vascular Events After Major Non-Cardiac Surgery With Preoperative Cardiac Biomarkers-2

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT05812248

Other Study ID Numbers:

NFEC-2022-223

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 13, 2023