Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

NCT04286685 | Unknown

• 1 other identifier: 29BRC19.0202 (TROPUTILE)
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 2

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.

Conditions

Perioperative Complication; Myocardial Injury

Keywords

Non cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative MINS incidence

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

  3 days after surgery

Secondary Outcomes (9)

• Number of Participants with cardiac arrest

  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 myocardial infarction

  3 months

• Number of Participants with stroke

  3 months

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU Brest

Brest, 29200, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

Study Officials

• Olivier HUET, MD, PhD

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier HUET, MD,PhD

CONTACT

+33298347288; olivier.huet@chu-brest.fr

Anaïs CAILLARD, MD

CONTACT

+33298347288; anais.caillard@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: January 7, 2020
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: August 7, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 21 months and ending five years following the publication
• 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

Locations

FR (2)