Troponin Elevation After Major Noncardiac Surgery 2

Study Overview
=================
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.

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

Conditions
-----------------
Perioperative Myocardial Infarction, Disability, Perioperative/Postoperative Complications

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Length of hospital stay | the number of days from the end of surgery until day of discharge | 1 week after surgery | 
| All-cause mortality |  | 1 week after surgery | 
| Major adverse cardiovascular event (MACE) |  | 6 months after surgery | 
| All-cause mortality |  | 6 months after surgery |