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

NCT05812248 | Recruiting

• 1 other identifier: NFEC-2022-223
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Noncardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with myocardial injury after noncardiac suregry (MINS)

  Within 30 days after the index surgery

Interventions

Perioperative cardiac biomarker measurement DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing major noncardiac suregry with medium-to-high risks for postoperative cardiac complications.

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Central Study Contacts

Bingcheng Zhao, MD

CONTACT

86-13763313653; zhaobch@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 13, 2023
• Study Start: July 1, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)