Clinical trial NCT02682966: Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
Official title: Direct Evaluation of Postoperative Myocardial Injury Using Coronary Computed Tomography Angiography After Non-Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Myocardial Injury
Keywords: troponin
coronary artery disease
pulmonary embolism
Computed Tomography Angiography
postoperative myocardial injury
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 354
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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.

Primary outcomes:
measure: Pulmonary Embolism
timeFrame: 1 week
Secondary outcomes:
measure: Obstructive coronary artery disease
timeFrame: 1 week
measure: Obstructive main stem or proximal left anterior descending (LAD) stenosis
timeFrame: 1 week
measure: 30-day MACE
timeFrame: 30 days
measure: 30-day all-cause mortality
timeFrame: 30-day
measure: major diagnostic changes
timeFrame: 1 week
measure: major therapeutic changes
timeFrame: 1 week
measure: bleeding
timeFrame: 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: UMC Utrecht
name: Wilton A van Klei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: