Postoperative Myocardial InjuryNCT02682966
Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
An observational study of Postoperative Myocardial Injury, run by UMC Utrecht.
Trial summary
This is a prospective study in patients who undergo routine postoperative troponin assessment after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L and a control group with troponin… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Myocardial Injury
- What is being tested?
- Coronary Computed Tomography Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of 60 years or older that undergo major (semi-)elective noncardiac surgery are eligible for study participation. Major (semi)-elective noncardiac surgery is defined as all surgical procedures requiring ≥ 24 hours of hospital admittance that have been preceded by a preoperative evaluation.
Who may be able to join
- ≥ 60 years old
- Major noncardiac surgery, defined as non-cardiac surgical procedures requiring hospital admittance > 24 hours
- Semi-elective surgery, defined as surgery that that has been preceded by a preoperative evaluation.
- ≥ 1 troponin assessment in the first 3 postoperative days as a part of the routine 'postoperative troponin assessment' protocol.
- For patients who undergo surgery more than once, the first surgery will be included in the analysis. Reoperations will not be included.
Who cannot join
- Typical anginal complaints
- Acute ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG
- Patients unable to fully comply to study needs (e.g. incompetent patients or patients unable to communicate in Dutch or English)
- Severe claustrophobia.
- Patients who have a life expectancy of less than three months.
- Patients who are too ill to undergo a CCTA or Ventilation/Perfusion (V/Q) scan.
About this study
This is a prospective study in patients who undergo routine postoperative troponin assessment after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L and a control group with troponin levels < 60ng/L. The primary aim of this study is to assess the association of PMI with pulmonary embolism. Additionally, the association between PMI and obstructive CAD will be investigated.
- Conditions
- Postoperative Myocardial Injury
- Being tested
- Coronary Computed Tomography Angiography
- Keywords
- troponin, coronary artery disease, pulmonary embolism, Computed Tomography Angiography, postoperative myocardial injury
- Medical subject headings
- Coronary Artery Disease, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography AngiographyRadiation
Coronary Computed Tomography Angiography will be performed in all participants
| Study group | Role | What they receive |
|---|---|---|
| PMI | Postoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L Receives: Radiation: Coronary Computed Tomography Angiography | |
| Control | postoperative troponin levels < 60 ng/L Receives: Radiation: Coronary Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Embolism
Pulmonary embolism (PE) on either Coronary Computed Tomography Angiography (CCTA) or Ventilation/Perfusion (V/Q) scan. PE on CCTA is defined as a sharply delineated pulmonary artery filling defect in at least two consecutive image sections of the CCTA, either located centrally within the vessel or with acute angles at its interface with the vessel wall. PE on V/Q scan is defined as at least one segmental or two subsegmental perfusion defects without corresponding abnormality on chest X-ray.
Measured: 1 week
Secondary outcomes (7)
Obstructive coronary artery disease
> 50% stenosis in one or more epicardial vessels on CCTA
Measured: 1 week
Obstructive main stem or proximal left anterior descending (LAD) stenosis
Incidence of obstructive (>50%) main stem or proximal left anterior descending (LAD) stenosis
Measured: 1 week
30-day MACE
Major adverse cardiovascular events within 30 postoperative days, which is defined as the composite of cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal ventricular fibrillation and ventricular arrhythmia with hemodynamic compromise.
Measured: 30 days
30-day all-cause mortality
Measured: 30-day
major diagnostic changes
Major Diagnostic change, which is defined as a clinically relevant change in diagnosis after CCTA in comparison to the most likely diagnosis before CCTA. The diagnosis prior to CCTA is made by the cardiology consultant and is based on routine clinical
Measured: 1 week
major therapeutic changes
Major Therapeutic change, which is defined as any change in in management of patients due to CCTA findings compared to the proposed treatment before CCTA
Measured: 1 week
bleeding
bleeding within one year after surgery, which is based on TIMI criteria
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilton A van Klei, UMC Utrecht
- Investigators
- Wilton A van Klei, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682966
- Sponsor's protocol ID
- DEPICT-NCS
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02682966
- Acronym / sponsor ID
- DEPICT-NCS
- Conditions
- Postoperative Myocardial Injury
- Keywords
- troponin, coronary artery disease, pulmonary embolism, Computed Tomography Angiography, postoperative myocardial injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Feb 2016 (estimated)
- 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.
This is a prospective study in patients who undergo routine postoperative troponin assessment after major (semi-)elective noncardiac surgery. Two groups are created based on postoperative troponin levels: Postoperative myocardial injury (PMI) group with troponin I levels ≥ 60 ng/L and a control group with troponin levels < 60ng/L. The primary aim of this study is to assess the association of PMI with pulmonary embolism. Additionally, the association between PMI and obstructive CAD will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMI | – | Radiation: Coronary Computed Tomography AngiographyPostoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L |
| Control | – | Radiation: Coronary Computed Tomography Angiographypostoperative troponin levels < 60 ng/L |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 60 years or older that undergo major (semi-)elective noncardiac surgery are eligible for study participation. Major (semi)-elective noncardiac surgery is defined as all surgical procedures requiring ≥ 24 hours of hospital admittance that have been preceded by a preoperative evaluation.
Key inclusion criteria (5 listed)
- ≥ 60 years old
- Major noncardiac surgery, defined as non-cardiac surgical procedures requiring hospital admittance > 24 hours
- Semi-elective surgery, defined as surgery that that has been preceded by a preoperative evaluation.
- ≥ 1 troponin assessment in the first 3 postoperative days as a part of the routine 'postoperative troponin assessment' protocol.
- For patients who undergo surgery more than once, the first surgery will be included in the analysis. Reoperations will not be included.
Key exclusion criteria (6 listed)
- Typical anginal complaints
- Acute ST-elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB) on ECG
- Patients unable to fully comply to study needs (e.g. incompetent patients or patients unable to communicate in Dutch or English)
- Severe claustrophobia.
- Patients who have a life expectancy of less than three months.
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 |
|---|---|---|
| Coronary Computed Tomography AngiographyCoronary Computed Tomography Angiography will be performed in all participants | Radiation | Control, PMI |
Primary outcome
Pulmonary Embolism
Time frame: 1 week
Pulmonary embolism (PE) on either Coronary Computed Tomography Angiography (CCTA) or Ventilation/Perfusion (V/Q) scan. PE on CCTA is defined as a sharply delineated pulmonary artery filling defect in at least two consecutive image sections of the CCTA, either located centrally within the vessel or with acute angles at its interface with the vessel wall. PE on V/Q scan is defined as at least one segmental or two subsegmental perfusion defects without corresponding abnormality on chest X-ray.
7 secondary outcomes
Obstructive coronary artery disease
Time frame: 1 week
Obstructive main stem or proximal left anterior descending (LAD) stenosis
Time frame: 1 week
30-day MACE
Time frame: 30 days
30-day all-cause mortality
Time frame: 30-day
major diagnostic changes
Time frame: 1 week
major therapeutic changes
Time frame: 1 week
bleeding
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Myocardial Injury
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
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Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
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CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
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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.
Wilton A van Klei, MD, PhD principal investigator
UMC Utrecht
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Myocardial Injury, run by UMC Utrecht.
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 5 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Pulmonary Embolism (time frame: 1 week). 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 17 Nov 2017.