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Clinical Trials/NCT04286685
NCT04286685
Recruiting
Not Applicable

Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study

University Hospital, Brest2 sites in 1 country1,600 target enrollmentJanuary 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Complication
Sponsor
University Hospital, Brest
Enrollment
1600
Locations
2
Primary Endpoint
Postoperative MINS incidence
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality.

There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality.

In this cohort study of orthopedic surgery patients (> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.

Registry
clinicaltrials.gov
Start Date
January 7, 2020
End Date
April 7, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \> 50 years
  • orthopedic surgery (hip, knee, spine)
  • written consent

Exclusion Criteria

  • no troponin measurement prior surgery
  • acute coronary syndrome
  • pulmonary embolism
  • refusing to participate
  • guardianship

Outcomes

Primary Outcomes

Postoperative MINS incidence

Time Frame: 3 days after surgery

Troponin elevation \> 5ng/l compared to previous measurement OR troponin elevation \> 65 ng/l

Secondary Outcomes

  • Mortality rate(3 months)
  • Number of Participants with myocardial infarction(3 months)
  • Number of Participants with stroke(3 months)
  • Number of Participants with an episode of acute pulmonary oedema(3 months)
  • Number of Participants with coronary angioplasty(3 months)
  • Number of Participants with transient stroke(3 months)
  • Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)(Inclusion)
  • Metabolic Equivalent of Task (MET)(Inclusion)
  • Number of Participants with cardiac arrest(3 months)

Study Sites (2)

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