An observational study in Perioperative Myocardial Infarction, Disability and Perioperative/Postoperative Complications, sponsored by UMC Utrecht. Status unknown at 3 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by UMC Utrecht · Observational
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.
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.
Exclusion Criteria:
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.
Time frame: 6 months after surgery
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.
Time frame: 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
Time frame: 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
Time frame: 1 week after surgery
Length of hospital stay
the number of days from the end of surgery until day of discharge
Time frame: 1 week after surgery
All-cause mortality
Time frame: 1 week after surgery
Major adverse cardiovascular event (MACE)
Time frame: 6 months after surgery
All-cause mortality
Time frame: 6 months after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UMC Utrecht