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Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04286685
Acronym
TROPUTILE
Enrollment
1600
Registered
2020-02-27
Start date
2020-01-07
Completion date
2025-04-07
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Injury, Perioperative Complication

Keywords

Non cardiac surgery

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative MINS incidence3 days after surgeryTroponin elevation \> 5ng/l compared to previous measurement OR troponin elevation \> 65 ng/l

Secondary

MeasureTime frameDescription
Number of Participants with an episode of acute pulmonary oedema3 monthsAcute pulmonary oedema
Number of Participants with coronary angioplasty3 monthsCoronary angioplasty
Number of Participants with myocardial infarction3 monthsMyocardial infarction
Number of Participants with stroke3 monthsStroke
Number of Participants with cardiac arrest3 monthsCardiac arrest
Mortality rate3 monthsDeath
Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)InclusionMinimum value = 0 Minimum value = 0, maximum value = 6, higher scores mean a worse outcome (higher peri operative mortality risk)
Metabolic Equivalent of Task (MET)InclusionMinimum 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.
Number of Participants with transient stroke3 monthsTransient stroke

Countries

France

Contacts

Primary ContactOlivier HUET, MD,PhD
olivier.huet@chu-brest.fr+33298347288
Backup ContactAnaïs CAILLARD, MD
anais.caillard@chu-brest.fr+33298347288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026