Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

NCT ID: NCT04286685

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2025-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Perioperative Complication Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier HUET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

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CHRU Brest

Brest, , France

Site Status RECRUITING

CHU Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier HUET, MD,PhD

Role: CONTACT

+33298347288

Anaïs CAILLARD, MD

Role: CONTACT

+33298347288

Facility Contacts

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Olivier HUET, MD, PhD

Role: primary

+33298347288

Anaïs CAILLARD, MD

Role: backup

+33298347288

Hélène BELOEIL, MD, PhD

Role: primary

Other Identifiers

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29BRC19.0202 (TROPUTILE)

Identifier Type: -

Identifier Source: org_study_id

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