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

NCT ID: NCT02682966

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Postoperative Myocardial Injury

Keywords

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troponin coronary artery disease pulmonary embolism Computed Tomography Angiography postoperative myocardial injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PMI

Postoperative Myocardial injury, postoperative troponin levels ≥ 60 ng/L

Coronary Computed Tomography Angiography

Intervention Type RADIATION

Coronary Computed Tomography Angiography will be performed in all participants

Control

postoperative troponin levels \< 60 ng/L

Coronary Computed Tomography Angiography

Intervention Type RADIATION

Coronary Computed Tomography Angiography will be performed in all participants

Interventions

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Coronary Computed Tomography Angiography

Coronary Computed Tomography Angiography will be performed in all participants

Intervention Type RADIATION

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Wilton A van Klei

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wilton A van Klei, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Other Identifiers

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DEPICT-NCS

Identifier Type: -

Identifier Source: org_study_id