Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
- Conditions
- Postoperative Myocardial Injury
- Interventions
- Radiation: Coronary Computed Tomography Angiography
- Registration Number
- NCT02682966
- Lead Sponsor
- UMC Utrecht
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 354
- ≥ 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PMI Coronary Computed Tomography Angiography Postoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L Control Coronary Computed Tomography Angiography postoperative troponin levels \< 60 ng/L
- Primary Outcome Measures
Name Time Method Pulmonary Embolism 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.
- Secondary Outcome Measures
Name Time Method Obstructive coronary artery disease 1 week \> 50% stenosis in one or more epicardial vessels on CCTA
30-day all-cause mortality 30-day major therapeutic changes 1 week 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
Obstructive main stem or proximal left anterior descending (LAD) stenosis 1 week Incidence of obstructive (\>50%) main stem or proximal left anterior descending (LAD) stenosis
30-day MACE 30 days 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.
major diagnostic changes 1 week 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
bleeding 1 year after surgery bleeding within one year after surgery, which is based on TIMI criteria