Perioperative ComplicationTROPUTILENCT04286685
Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury
An observational study of Perioperative Complication and Myocardial Injury, run by University Hospital, Brest at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Complication, Myocardial Injury
- How many people
- 1,600 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jan 2020to 7 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged of 50 years and more, with elective orthopedic surgery in Brest community-affiliated hospital
Who may be able to join
- > 50 years
- orthopedic surgery (hip, knee, spine)
- written consent
Who cannot join
- no troponin measurement prior surgery
- sepsis
- acute coronary syndrome
- pulmonary embolism
- refusing to participate
- guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHRU Brest
Brest, 29200
Olivier HUET, MD, PhD, +33298347288, olivier.huet@chu-brest.fr
Anaïs CAILLARD, MD, +33298347288, anais.caillard@chu-brest.fr
- Recruiting
CHU Rennes
Rennes, 35033
Hélène BELOEIL, MD, PhD, helene.beloeil@chu-rennes.fr
About this study
Official title: Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative MINS incidence
Troponin elevation > 5ng/l compared to previous measurement OR troponin elevation > 65 ng/l
Measured: 3 days after surgery
Secondary outcomes (9)
Number of Participants with cardiac arrest
Cardiac arrest
Measured: 3 months
Number of Participants with an episode of acute pulmonary oedema
Acute pulmonary oedema
Measured: 3 months
Number of Participants with coronary angioplasty
Coronary angioplasty
Measured: 3 months
Number of Participants with myocardial infarction
Myocardial infarction
Measured: 3 months
Number of Participants with stroke
Stroke
Measured: 3 months
Number of Participants with transient stroke
Transient stroke
Measured: 3 months
Mortality rate
Death
Measured: 3 months
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)
Measured: Inclusion
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.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start7 Jan 2020
- Primary completion7 Apr 2025 (estimated)
- Study completion7 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HUET, MD, PhD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286685
- Sponsor's protocol ID
- 29BRC19.0202 (TROPUTILE)
- Acronym
- TROPUTILE
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study
- ClinicalTrials.gov ID
- NCT04286685
- Acronym / sponsor ID
- TROPUTILE / 29BRC19.0202 (TROPUTILE)
- Conditions
- Perioperative Complication, Myocardial Injury
- Keywords
- Non cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 7 Apr 2025 (estimated)
- Study completion
- 7 Apr 2025 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged of 50 years and more, with elective orthopedic surgery in Brest community-affiliated hospital
Key inclusion criteria (3 listed)
- > 50 years
- orthopedic surgery (hip, knee, spine)
- written consent
Key exclusion criteria (6 listed)
- no troponin measurement prior surgery
- sepsis
- acute coronary syndrome
- pulmonary embolism
- refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative MINS incidence
Time frame: 3 days after surgery
Troponin elevation > 5ng/l compared to previous measurement OR troponin elevation > 65 ng/l
9 secondary outcomes
Number of Participants with cardiac arrest
Time frame: 3 months
Number of Participants with an episode of acute pulmonary oedema
Time frame: 3 months
Number of Participants with coronary angioplasty
Time frame: 3 months
Number of Participants with myocardial infarction
Time frame: 3 months
Number of Participants with stroke
Time frame: 3 months
Number of Participants with transient stroke
Time frame: 3 months
Mortality rate
Time frame: 3 months
Revised Cardiac Risk Index for Pre-Operative Risk (Lee score)
Time frame: Inclusion
Metabolic Equivalent of Task (MET)
Time frame: Inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier HUET, MD, PhD principal investigator
CHRU BREST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication and Myocardial Injury, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HUET, MD,PhD (+33298347288, olivier.huet@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative MINS incidence (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.