NCT02682966

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

February 3, 2016

Last Update Submit

November 14, 2017

Conditions

Postoperative Myocardial Injury

Keywords

troponincoronary artery diseasepulmonary embolismComputed Tomography Angiographypostoperative myocardial injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Obstructive coronary artery disease

    1 week

  • Obstructive main stem or proximal left anterior descending (LAD) stenosis

    1 week

  • 30-day MACE

    30 days

  • 30-day all-cause mortality

    30-day

  • major diagnostic changes

    1 week

  • +2 more secondary outcomes

Study Arms (2)

PMI

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

Radiation: Coronary Computed Tomography Angiography

Control

postoperative troponin levels \< 60 ng/L

Radiation: Coronary Computed Tomography Angiography

Interventions

Coronary Computed Tomography AngiographyRADIATION

Coronary Computed Tomography Angiography will be performed in all participants

ControlPMI

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseasePulmonary Embolism

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and Thrombosis

Study Officials

  • Wilton A van Klei, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 17, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

November 17, 2017

Record last verified: 2017-11