Myocardial InjuryREMAINNCT06728111
Unraveling Perioperative Myocardial Injury
An observational study of Myocardial Injury and Myocardial Injury After Non-Cardiac Surgery, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Injury, Myocardial Injury After Non-Cardiac Surgery
- What is being tested?
- High sensitive Troponin T
- How many people
- 1,114 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jul 2023to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population to be studied consists of all non-cardiac surgical patients who underwent surgery at Erasmus MC in the period 2017-2023.
Who may be able to join
- Age > 18 year of age
- Undergoing non-cardiac surgery in the Erasmus MC, with (high-sensitive) Troponin T > 50 ng/L measured in any of the first three days after surgery.
Who cannot join
- Re-operations within the study period.
- Daycare surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: unRaveling pErioperative MyocArdial INjury
The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.
Read the detailed description
As above
- Being tested
- High sensitive Troponin T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High sensitive Troponin TOther
The baseline population will consist of all patients who underwent a form of non-cardiac surgery. Baseline variables, medication use, type of surgery and perioperative hemodynamic and laboratory variables will be extracted from the hospital information system. One year mortality is registered, as well as major vascular events. This is in line with previous publications from our group. The adjudication strategy used for patients with myocardial injury. For the adjudication process minimal two senior anesthesiologists will be invited. Two members with at least one senior anesthesiologist will receive a sample of patients to adjudicate. Together the entire panel will adjudicate all patients. The goal to investigate the differences between the raters.
What is being measured
The primary outcome is the main question the study is designed to answer.
Main etiologies elevated troponin T
The primary endpoint is a description of the main etiologies found within patients with an elevated troponin T after non cardiac surgery.
Measured: from enrollment
Secondary outcomes (1)
Differences in adjudication
Differences in the adjudication process between different doctors will be assessed according to intraclass coeficients and Fleisch Kappa
Measured: from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start24 Jul 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Retrospective
- Enrolment
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix van Lier, Erasmus Medical Center
- Investigators
- Sanne Hoeks, PhD, Study director, EpidemiologistFelix van Lier, PhD, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728111
- Sponsor's protocol ID
- 10945
- Acronym
- REMAIN
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- unRaveling pErioperative MyocArdial INjury
- ClinicalTrials.gov ID
- NCT06728111
- Acronym / sponsor ID
- REMAIN / 10945
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied consists of all non-cardiac surgical patients who underwent surgery at Erasmus MC in the period 2017-2023.
Key inclusion criteria (2 listed)
- Age > 18 year of age
- Undergoing non-cardiac surgery in the Erasmus MC, with (high-sensitive) Troponin T > 50 ng/L measured in any of the first three days after surgery.
Key exclusion criteria (2 listed)
- Re-operations within the study period.
- Daycare surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High sensitive Troponin TThe baseline population will consist of all patients who underwent a form of non-cardiac surgery. Baseline variables, medication use, type of surgery and perioperative hemodynamic and laboratory variables will be extracted from the hospital information system. One year mortality is registered, as well as major vascular events. This is in line with previous publications from our group. The adjudication strategy used for patients with myocardial injury. For the adjudication process minimal two senior anesthesiologists will be invited. Two members with at least one senior anesthesiologist will receive a sample of patients to adjudicate. Together the entire panel will adjudicate all patients. The goal to investigate the differences between the raters. | Other | – |
Primary outcome
Main etiologies elevated troponin T
Time frame: from enrollment
The primary endpoint is a description of the main etiologies found within patients with an elevated troponin T after non cardiac surgery.
1 secondary outcome
Differences in adjudication
Time frame: from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Sanne Hoeks, PhD study director
Epidemiologist
Felix van Lier, PhD principal investigator
Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury and Myocardial Injury After Non-Cardiac Surgery, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main etiologies elevated troponin T (time frame: from enrollment). 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 11 Dec 2024.