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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Myocardial Injury

Intervention / Treatment
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* Radiation: Coronary Computed Tomography Angiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PMI<br>Postoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L | Radiation: Coronary Computed Tomography Angiography<br>* Coronary Computed Tomography Angiography will be performed in all participants<br>|
| Control<br>postoperative troponin levels < 60 ng/L | Radiation: Coronary Computed Tomography Angiography<br>* Coronary Computed Tomography Angiography will be performed in all participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive coronary artery disease | > 50% stenosis in one or more epicardial vessels on CCTA | 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 | 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. | 30 days | 
| 30-day all-cause mortality |  | 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 | 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 | 1 week | 
| bleeding | bleeding within one year after surgery, which is based on TIMI criteria | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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troponin, coronary artery disease, pulmonary embolism, Computed Tomography Angiography, postoperative myocardial injury