Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

Myocardial Injury Clinical Trial

— TROPUTILE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04286685
• Other study ID #: 29BRC19.0202 (TROPUTILE)
• Status: Recruiting
• Start date: January 7, 2020
• Est. completion date: April 7, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: Olivier HUET, MD,PhD
• Phone: +33298347288
• Email: olivier.huet[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: April 7, 2024
• Est. primary completion date: April 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Injury
• Perioperative Complication
• Wounds and Injuries

Locations

Country	Name	City	State
France	CHRU Brest	Brest
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative MINS incidence	Troponin elevation > 5ng/l compared to previous measurement OR troponin elevation > 65 ng/l	3 days after surgery
Secondary	Number of Participants with cardiac arrest	Cardiac arrest	3 months
Secondary	Number of Participants with an episode of acute pulmonary oedema	Acute pulmonary oedema	3 months
Secondary	Number of Participants with coronary angioplasty	Coronary angioplasty	3 months
Secondary	Number of Participants with myocardial infarction	Myocardial infarction	3 months
Secondary	Number of Participants with stroke	Stroke	3 months
Secondary	Number of Participants with transient stroke	Transient stroke	3 months
Secondary	Mortality rate	Death	3 months
Secondary	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
Secondary	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