Troponin Elevation After Major Noncardiac Surgery 2

NCT ID: NCT03408522

Last Updated: 2019-01-16

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-29

Study Completion Date

2019-12-31

Brief Summary

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Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in cardiac troponin, are also at substantially increased risk of additional cardiac and noncardiac complications. Accordingly, it is plausible to assume that PMI negatively affects quality of life in terms of disability. The aim of this study is to investigate and compare the independent prognostic effects of the different PMI phenotypes (myocardial infarction and non-infarct troponin elevations) and noncardiac complications on disability in patients undergoing elective noncardiac surgery.

Detailed Description

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Conditions

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Perioperative Myocardial Infarction Disability Perioperative/Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 60 years old;
* Major noncardiac surgery defined as all noncardiac surgical procedures requiring an expected hospital stay of at least 24 hours;
* Elective surgery, defined as surgery that that has been preceded by a preoperative consultation at the anesthesia preoperative screening outpatient clinic.

Exclusion Criteria

* Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English).
* Patients with an American Society of Anesthesiologists (ASA) Physical status 5
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role collaborator

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

prof. dr.

W. Scott Beattie, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

prof. dr.

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Canada Netherlands

Central Contacts

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Wilton A van Klei, MD, PhD

Role: CONTACT

+3188 75 59475

Lisette M Vernooij, Msc

Role: CONTACT

Facility Contacts

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W. Scott Beattie, MD PhD FRCPC

Role: primary

W. Scott Beattie, MD PhD FRCPC

Role: primary

Wilton A van Klei, MD, PhD

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TEAMS2

Identifier Type: -

Identifier Source: org_study_id

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