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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Myocardial Injury
• Intervention / Treatment: Radiation: Coronary Computed Tomography Angiography

• Study Type: Observational
• Enrollment (Anticipated): 354

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PMI; Postoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L	Radiation: Coronary Computed Tomography Angiography; Coronary Computed Tomography Angiography will be performed in all participants
Control; postoperative troponin levels < 60 ng/L	Radiation: Coronary Computed Tomography Angiography; Coronary Computed Tomography Angiography will be performed in all participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Wilton A van Klei, MD, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: coronary artery disease; pulmonary embolism; troponin; Computed Tomography Angiography; postoperative myocardial injury
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: DEPICT-NCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED