Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

Recruiting

• Conditions: Perioperative Complication; Myocardial Injury

• Registration Number: NCT04286685
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2023-12
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-04-07
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative MINS incidence	3 days after surgery	Troponin elevation \> 5ng/l compared to previous measurement OR troponin elevation \> 65 ng/l

Secondary Outcome Measures

Name	Time	Method
Number of Participants with myocardial infarction	3 months	Myocardial infarction
Number of Participants with stroke	3 months	Stroke
Number of Participants with an episode of acute pulmonary oedema	3 months	Acute pulmonary oedema
Number of Participants with coronary angioplasty	3 months	Coronary angioplasty
Number of Participants with transient stroke	3 months	Transient stroke
Mortality rate	3 months	Death
Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)	Inclusion	Minimum value = 0 Minimum value = 0, maximum value = 6, higher scores mean a worse outcome (higher peri operative mortality risk)
Metabolic Equivalent of Task (MET)	Inclusion	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.
Number of Participants with cardiac arrest	3 months	Cardiac arrest

Trial Locations

Locations (2)

CHU Rennes; 🇫🇷 Rennes, France

CHRU Brest; 🇫🇷 Brest, France