Unraveling Perioperative Myocardial Injury (REMAIN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Injury; Myocardial Injury After Non-Cardiac Surgery
• Intervention / Treatment: Other: High sensitive Troponin T

Detailed Description

As above

• Study Type: Observational
• Enrollment (Actual): 1114

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in adjudication	Differences in the adjudication process between different doctors will be assessed according to intraclass coeficients and Fleisch Kappa	from enrollment

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Study Director: Sanne Hoeks, PhD, Epidemiologist; Principal Investigator: Felix van Lier, PhD, Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 10945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No