Clinical trial NCT03408522: Troponin Elevation After Major Noncardiac Surgery 2
Official title: Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: A Prospective Cohort Study - Troponin Elevation After Major Noncardiac Surgery 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Myocardial Infarction
Disability
Perioperative/Postoperative Complications
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2018-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disability
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Disability free survival
timeFrame: 6 months after surgery
measure: Major adverse cardiovascular event (MACE)
timeFrame: 1 week after surgery
measure: Noncardiac major adverse postoperative events (MAPE)
timeFrame: 1 week after surgery
measure: Length of hospital stay
timeFrame: 1 week after surgery
measure: All-cause mortality
timeFrame: 1 week after surgery
measure: Major adverse cardiovascular event (MACE)
timeFrame: 6 months after surgery
measure: All-cause mortality
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: prof. dr.
name: Wilton A van Klei, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: prof. dr.
name: W. Scott Beattie, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: