Troponin Elevation After Major Noncardiac Surgery 2

Perioperative/Postoperative Complications Clinical Trial

— TEAMS2  

Official title:

Clinical Characteristics and Functional Outcomes of Postoperative Myocardial Injury: A Prospective Cohort Study - Troponin Elevation After Major Noncardiac Surgery 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03408522
• Other study ID #: TEAMS2
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Disability
• Infarction
• Myocardial Infarction
• Perioperative Myocardial Infarction
• Perioperative/Postoperative Complications
• Postoperative Complications

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