Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury (TROPUTILE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Injury; Perioperative Complication

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Olivier Huet, MD,PhD; Phone Number: +33298347288; Email: olivier.huet@chu-brest.fr
• Study Contact Backup: Name: Anaïs CAILLARD, MD; Phone Number: +33298347288; Email: anais.caillard@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU Brest
    • Contact: Anaïs CAILLARD, MD; Phone Number: +33298347288; Email: anais.caillard@chu-brest.fr
    • Contact: Olivier HUET, MD, PhD; Phone Number: +33298347288; Email: olivier.huet@chu-brest.fr
  • Rennes, France, 35033
    • Recruiting
    • CHU Rennes
    • Contact: Hélène BELOEIL, MD, PhD; Email: helene.beloeil@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients aged of 50 years and more, with elective orthopedic surgery in Brest community-affiliated hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative MINS incidence	Troponin elevation > 5ng/l compared to previous measurement OR troponin elevation > 65 ng/l	3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with cardiac arrest	Cardiac arrest	3 months
Number of Participants with an episode of acute pulmonary oedema	Acute pulmonary oedema	3 months
Number of Participants with coronary angioplasty	Coronary angioplasty	3 months
Number of Participants with myocardial infarction	Myocardial infarction	3 months
Number of Participants with stroke	Stroke	3 months
Number of Participants with transient stroke	Transient stroke	3 months
Mortality rate	Death	3 months
Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)	Minimum value = 0 Minimum value = 0, maximum value = 6, higher scores mean a worse outcome (higher peri operative mortality risk)	Inclusion
Metabolic Equivalent of Task (MET)	Minimum value = 1, Maximum value= 10, a low score (MET <4) is associated with a capacity to do some light intensity activities and is associated with cardiovascular risk.	Inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Olivier HUET, MD, PhD, CHRU Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Estimated): April 7, 2025
• Study Completion (Estimated): April 7, 2025

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Non cardiac surgery
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 29BRC19.0202 (TROPUTILE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning 21 months and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the international committee of Brest UH . Requestors will be required to sign and complete a data acess agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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