Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Myocardial Injury
- Sponsor
- UMC Utrecht
- Enrollment
- 354
- Primary Endpoint
- Pulmonary Embolism
- Last Updated
- 8 years ago
Overview
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.
Investigators
Wilton A van Klei
Prof. dr.
UMC Utrecht
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Obstructive coronary artery disease(1 week)
- 30-day all-cause mortality(30-day)
- major therapeutic changes(1 week)
- Obstructive main stem or proximal left anterior descending (LAD) stenosis(1 week)
- 30-day MACE(30 days)
- major diagnostic changes(1 week)
- bleeding(1 year after surgery)