Unraveling Perioperative Myocardial Injury

NCT06728111 | Active Not Recruiting

• 1 other identifier: 10945
• Study Type: observational
• Target: 1,114
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.

Conditions

Myocardial Injury; Myocardial Injury After Non-Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Main etiologies elevated troponin T

  The primary endpoint is a description of the main etiologies found within patients with an elevated troponin T after non cardiac surgery.

  from enrollment

Secondary Outcomes (1)

• Differences in adjudication

  from enrollment

Interventions

High sensitive Troponin T OTHER

The baseline population will consist of all patients who underwent a form of non-cardiac surgery. Baseline variables, medication use, type of surgery and perioperative hemodynamic and laboratory variables will be extracted from the hospital information system. One year mortality is registered, as well as major vascular events. This is in line with previous publications from our group. The adjudication strategy used for patients with myocardial injury. For the adjudication process minimal two senior anesthesiologists will be invited. Two members with at least one senior anesthesiologist will receive a sample of patients to adjudicate. Together the entire panel will adjudicate all patients. The goal to investigate the differences between the raters.

Eligibility Criteria

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

Study Population

The population to be studied consists of all non-cardiac surgical patients who underwent surgery at Erasmus MC in the period 2017-2023.

You may qualify if:

• Age \> 18 year of age
• Undergoing non-cardiac surgery in the Erasmus MC, with (high-sensitive) Troponin T \> 50 ng/L measured in any of the first three days after surgery.

You may not qualify if:

• Re-operations within the study period.
• Daycare surgery

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

Location

Study Officials

• Sanne Hoeks, PhD

  Epidemiologist

  STUDY DIRECTOR

• Felix van Lier, PhD

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: July 24, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

NL (1)