Myocardial Injury After Non-cardiac SurgeryNCT05933837
Troponin I Level and Mortality in Acute Abdominal Surgery
An observational study of Myocardial Injury After Non-cardiac Surgery and Abdomen, Acute, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery. MINS is defined as at least one increased single measurement of plasma troponin I (TnI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Injury After Non-cardiac Surgery, Abdomen, Acute
- What is being tested?
- Troponin I
- How many people
- 341 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2019to 28 Feb 2022
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for gastrointestinal perforation, obstruction due to volvulus, tumour, strangulated hernia or adhesions, mesenterial ischemia or necrosis, or anastomotic leakage after gastrointestinal surgery.
Who may be able to join
- 18 years or older
- Patients undergoing acute high-risk abdominal surgery
Who cannot join
- Patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage
- If further treatment postoperatively was assessed as futile and terminated immediately after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Troponin I Levels and Mortality Among Patients Undergoing Acute High-risk Abdominal Surgery - a Cohort Study
The goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery.
MINS is defined as at least one increased single measurement of plasma troponin I (TnI). TnI-dynamic is defined as either two succeeding measurements of TnI > 59 ng/l with an increase/fall of more than 20%, or by one measurements of TnI > 59 ng/l with a succeeding measurement of TnI < 59 ng/l and a decrease of more than 50%.
Read more
Participants will have plasma TnI measured 6-12 hours postoperatively and on each of the following four postoperative days. Follow-up will be minimum one year after surgery.
The aim of the study is to determine:
- The incidence of MINS within the first four postoperative days
- The incidence of dynamic TnI changes
- The association between MINS and dynamic TnI changes respectively and all-course short-term mortality
Read the detailed description
Gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. Myocardial injury after non-cardiac surgery (MINS) is a frequent but often unrecognized postoperative complication. MINS is associated with an increased risk of other cardiac complications and 30-day mortality. However, the literature on MINS is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic TnI-criteria used for acute myocardial injury has any association with mortality in patients with MINS.
This study aims to estimate the incidence of MINS in patients undergoing AHA surgery, and the association between the short-term mortality and MINS defined as a single increased measurement of TnI and as TnI dynamics respectively.
- Being tested
- Troponin I
- Keywords
- Myocardial injury after non-cardiac surgery, Abdomen, Acute, Troponin I, Myocardial Injury, Emergency surgery
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin IDiagnostic test
Measurements of plasma Troponin I 6-12 hours and on the first four postoperative days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MINS | Troponin I level equal to or above 59 ng/L Receives: Diagnostic Test: Troponin I | |
| Patients without MINS | Troponin I level under 59 ng/L Receives: Diagnostic Test: Troponin I |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MINS within the first four postoperative days
Postoperative troponin I level equal to or above 59 ng/L
Measured: The first four postoperative days
Secondary outcomes (1)
The incidence of dynamic plasma Troponin I changes
Patients with postoperative troponin I level equal to or above 59 ng/L and a change of +20%
Measured: The first four postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Mar 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Injury After Non-cardiac SurgeryStudies of the same condition, open and under way.
- 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
- 341 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Tiffanie Bendtz Kanstrup, Nordsjaellands Hospital
- Investigators
- Claus A Bertelsen, Study chair, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933837
- Sponsor's protocol ID
- P-2020-507
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanstrup CTB, Serup CM, Svarre KJ, Rasmussen MC, Lundstrom LH, Kleif J, Bertelsen CA. Association between troponin I levels and mortality among patients undergoing acute high-risk abdominal surgery-A cohort study. World J Surg. 2024 Feb;48(2):361-370. doi: 10.1002/wjs.12035. Epub 2024 Jan 12.
PubMed 38284768
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Troponin I Levels and Mortality Among Patients Undergoing Acute High-risk Abdominal Surgery - a Cohort Study
- ClinicalTrials.gov ID
- NCT05933837
- Acronym / sponsor ID
- P-2020-507
- Keywords
- Myocardial injury after non-cardiac surgery, Abdomen, Acute, Troponin I, Myocardial Injury, Emergency surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jul 2023 (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 goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery.
MINS is defined as at least one increased single measurement of plasma troponin I (TnI). TnI-dynamic is defined as either two succeeding measurements of TnI > 59 ng/l with an increase/fall of more than 20%, or by one measurements of TnI > 59 ng/l with a succeeding measurement of TnI < 59 ng/l and a decrease of more than 50%.
Participants will have plasma TnI measured 6-12 hours postoperatively and on each of the following four postoperative days. Follow-up will be minimum one year after surgery.
The aim of the study is to determine:
- The incidence of MINS within the first four postoperative days
- The incidence of dynamic TnI changes
- The association between MINS and dynamic TnI changes respectively and all-course short-term mortality
Detailed description
Gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. Myocardial injury after non-cardiac surgery (MINS) is a frequent but often unrecognized postoperative complication. MINS is associated with an increased risk of other cardiac complications and 30-day mortality. However, the literature on MINS is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic TnI-criteria used for acute myocardial injury has any association with mortality in patients with MINS.
This study aims to estimate the incidence of MINS in patients undergoing AHA surgery, and the association between the short-term mortality and MINS defined as a single increased measurement of TnI and as TnI dynamics respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MINS | – | Diagnostic Test: Troponin ITroponin I level equal to or above 59 ng/L |
| Patients without MINS | – | Diagnostic Test: Troponin ITroponin I level under 59 ng/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for gastrointestinal perforation, obstruction due to volvulus, tumour, strangulated hernia or adhesions, mesenterial ischemia or necrosis, or anastomotic leakage after gastrointestinal surgery.
Key inclusion criteria (2 listed)
- 18 years or older
- Patients undergoing acute high-risk abdominal surgery
Key exclusion criteria (2 listed)
- Patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage
- If further treatment postoperatively was assessed as futile and terminated immediately after 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 |
|---|---|---|
| Troponin IMeasurements of plasma Troponin I 6-12 hours and on the first four postoperative days after surgery. | Diagnostic test | Patients with MINS, Patients without MINS |
Primary outcome
The incidence of MINS within the first four postoperative days
Time frame: The first four postoperative days
Postoperative troponin I level equal to or above 59 ng/L
1 secondary outcome
The incidence of dynamic plasma Troponin I changes
Time frame: The first four postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 38284768Kanstrup CTB, Serup CM, Svarre KJ, Rasmussen MC, Lundstrom LH, Kleif J, Bertelsen CA. Association between troponin I levels and mortality among patients undergoing acute high-risk abdominal surgery-A cohort study. World J Surg. 2024 Feb;48(2):361-370. doi: 10.1002/wjs.12035. Epub 2024 Jan 12.
- Individual participant dataSharing planned: No
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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.
Claus A Bertelsen study chair
Nordsjaellands Hospital
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 After Non-cardiac Surgery and Abdomen, Acute, run by Nordsjaellands Hospital at 1 site in Denmark.
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: finished, as of the sponsor's last update on 6 Jul 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of MINS within the first four postoperative days (time frame: The first four postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05933837, which also lists 1 linked publication.
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 6 Jul 2023.