Surgery--ComplicationsNCT03605134
The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery
An observational study of Surgery--Complications and Mortality, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Surgery--Complications, Mortality, Elderly
- What is being tested?
- level of cardiac troponin and diastolic function assessment
- How many people
- 63 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Aug 2018to 7 Aug 2019
- 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 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All surgical patients above 75 years old
Who may be able to join
- All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
- Only those patients will be included who are planned for elective and major surgery.
Who cannot join
- Patients under the age of 75
- Intraoperative mortality
- Eye surgery
- Cardiac or thoracic surgery
- Patients undergoing surgery which is not withheld as major surgery
- For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included
Trial locations and contacts
1 site in 1 country.
About this study
To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.
Read the detailed description
Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.
Several studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.
Up till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.
This study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).
- Conditions
- Surgery--Complications, Mortality, Elderly
- Being tested
- level of cardiac troponin, diastolic function assessment
- Keywords
- troponin, diastolic function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of cardiac troponinDiagnostic test
blood test
diastolic function assessmentDiagnostic test
transthoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| study group | level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography Receives: Diagnostic Test: level of cardiac troponin; Diagnostic Test: diastolic function assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical mortality
30 days mortality
Measured: 30 days
Secondary outcomes (1)
diastolic function
transthoracic echocardiography
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start23 Aug 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Why it stopped: Not enough patient recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jan Poelaert, PhD, MD, Principal investigator, Universitair Ziekenhuis BrusselPatrice Forget, PhD, MD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605134
- Sponsor's protocol ID
- Troponin
- Status last verified
- Oct 2025
- First submitted
- 28 Jun 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT03605134
- Acronym / sponsor ID
- Troponin
- Conditions
- Surgery--Complications, Mortality, Elderly
- Keywords
- troponin, diastolic function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patient recruited
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 30 Jul 2018 (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.
To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.
Detailed description
Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.
Several studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.
Up till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.
This study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: level of cardiac troponin, Diagnostic Test: diastolic function assessmentlevel of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All surgical patients above 75 years old
Key inclusion criteria (2 listed)
- All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
- Only those patients will be included who are planned for elective and major surgery.
Key exclusion criteria (6 listed)
- Patients under the age of 75
- Intraoperative mortality
- Eye surgery
- Cardiac or thoracic surgery
- Patients undergoing surgery which is not withheld as major 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 |
|---|---|---|
| level of cardiac troponinblood test | Diagnostic test | study group |
| diastolic function assessmenttransthoracic echocardiography | Diagnostic test | study group |
Primary outcome
surgical mortality
Time frame: 30 days
30 days mortality
1 secondary outcome
diastolic function
Time frame: 3 days
Results and safety
The study was stopped early (reason given: Not enough patient recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
jan Poelaert, PhD, MD principal investigator
Universitair Ziekenhuis Brussel
Patrice Forget, PhD, MD study chair
Universitair Ziekenhuis Brussel
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 Surgery--Complications and Mortality, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 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: stopped early, as of the sponsor's last update on 18 Nov 2025. 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 Belgium. 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 was stopped early (reason given: Not enough patient recruited). Results are not available in the source record.
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?
surgical mortality (time frame: 30 days). 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 18 Nov 2025.