Skip to content

Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery

Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02682966
Enrollment
354
Registered
2016-02-17
Start date
2016-09-30
Completion date
2020-12-31
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Myocardial Injury

Keywords

troponin, coronary artery disease, pulmonary embolism, Computed Tomography Angiography, postoperative myocardial injury

Brief 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 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.

Interventions

RADIATIONCoronary Computed Tomography Angiography

Coronary Computed Tomography Angiography will be performed in all participants

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Embolism1 weekPulmonary 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.

Secondary

MeasureTime frameDescription
Obstructive main stem or proximal left anterior descending (LAD) stenosis1 weekIncidence of obstructive (\>50%) main stem or proximal left anterior descending (LAD) stenosis
30-day MACE30 daysMajor 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.
30-day all-cause mortality30-day
Obstructive coronary artery disease1 week\> 50% stenosis in one or more epicardial vessels on CCTA
major therapeutic changes1 weekMajor Therapeutic change, which is defined as any change in in management of patients due to CCTA findings compared to the proposed treatment before CCTA
bleeding1 year after surgerybleeding within one year after surgery, which is based on TIMI criteria
major diagnostic changes1 weekMajor 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026