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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03408522
Other study ID # TEAMS2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 29, 2018
Est. completion date December 31, 2019

Study information

Verified date January 2019
Source UMC Utrecht
Contact Wilton A van Klei, MD, PhD
Phone +3188 75 59475
Email w.a.vanklei@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario
Canada Toronto Western Hospital Toronto Ontario
Netherlands UMC Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht University Health Network, Toronto

Countries where clinical trial is conducted

Canada,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disability 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 Disability free survival 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
Secondary Major adverse cardiovascular event (MACE) 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
Secondary Noncardiac major adverse postoperative events (MAPE) 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
Secondary Length of hospital stay the number of days from the end of surgery until day of discharge 1 week after surgery
Secondary All-cause mortality 1 week after surgery
Secondary Major adverse cardiovascular event (MACE) 6 months after surgery
Secondary All-cause mortality 6 months after surgery
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