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OpenTrials
Active, Not Recruiting

NCT Number: NCT06728111

Unraveling Perioperative Myocardial Injury

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myocardial Injury Myocardial Injury After Non-Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Center

Rotterdam, Netherlands

About this study

As above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Main etiologies elevated troponin T

    Time frame: from enrollment

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

Secondary outcomes

  1. Differences in adjudication

    Time frame: from enrollment

    Differences in the adjudication process between different doctors will be assessed according to intraclass coeficients and Fleisch Kappa

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: REMAIN

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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