- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03408522
Troponin Elevation After Major Noncardiac Surgery 2 (TEAMS2)
January 14, 2019 updated by: Wilton A van Klei, UMC Utrecht
Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: A Prospective Cohort Study - Troponin Elevation After Major Noncardiac Surgery 2
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wilton A van Klei, MD, PhD
- Phone Number: +3188 75 59475
- Email: w.a.vanklei@umcutrecht.nl
Study Contact Backup
- Name: Lisette M Vernooij, Msc
- Email: l.m.vernooij@umcutrecht.nl
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Not yet recruiting
- Toronto Western Hospital
-
Contact:
- W. Scott Beattie, MD PhD FRCPC
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Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Toronto General Hospital
-
Contact:
- W. Scott Beattie, MD PhD FRCPC
-
-
-
-
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Utrecht, Netherlands
- Recruiting
- UMC Utrecht
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Contact:
- Wilton A van Klei, MD, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 aged 60 years or older, undergoing major elective non-cardiac surgery under general or spinal anesthesia with an expected hospital admittance of at least 24 hours.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: 6 months after surgery
|
Disability is expressed by the World Health Organization Disability Assessment Score 2.0 (WHODAS 2.0), which is based on difficulties experienced by the respondent in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days.
Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death.
|
6 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 6 months after surgery
|
6 months after surgery
|
|
Disability free survival
Time Frame: 6 months after surgery
|
Disability free survival is defined as being alive with a WHODAS 2.0 score ≤ 25% and no increase of the pre-operative score ≥ 25% at 6 months after surgery.
|
6 months after surgery
|
Major adverse cardiovascular event (MACE)
Time Frame: 1 week after surgery
|
MACE is defined as a composite outcome consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal ventricular fibrillation, ventricular arrhythmia with hemodynamic compromise, atrial fibrillation requiring cardioversion, pulmonary embolism, stroke
|
1 week after surgery
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Noncardiac major adverse postoperative events (MAPE)
Time Frame: 1 week after surgery
|
Noncardiac MAPE is a composite outcome consisting of respiratory failure (including pneumonia and hypoxia or hypercapnia leading to ICU admission for respiratory support), sepsis, renal failure, unplanned ICU admission, unplanned medium care admission, reoperation
|
1 week after surgery
|
Length of hospital stay
Time Frame: 1 week after surgery
|
the number of days from the end of surgery until day of discharge
|
1 week after surgery
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All-cause mortality
Time Frame: 1 week after surgery
|
1 week after surgery
|
|
Major adverse cardiovascular event (MACE)
Time Frame: 6 months after surgery
|
6 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wilton A van Klei, MD PhD, Prof. Dr.
- Principal Investigator: W. Scott Beattie, MD PhD FRCPC, Prof. Dr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2018
Primary Completion (Anticipated)
June 30, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
January 15, 2018
First Submitted That Met QC Criteria
January 22, 2018
First Posted (Actual)
January 24, 2018
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAMS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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