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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wilton A van Klei, MD, PhD | Contact | +3188 75 59475 | w.a.vanklei@umcutrecht.nl | |
| Lisette M Vernooij, Msc | Contact | l.m.vernooij@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Wilton A van Klei, MD PhD | prof. dr. | Principal Investigator |
| W. Scott Beattie, MD PhD FRCPC | prof. dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38057252 | Derived | Vernooij LM, van Waes JAR, Grobben RB, van Lier F, Feng S, Machina M, McKenny M, Nathoe HM, Wijeysundera DN, van Klei WA, Beattie WS. Postoperative myocardial injury phenotypes and self-reported disability in patients undergoing noncardiac surgery: a multicentre observational study. Br J Anaesth. 2024 Jan;132(1):35-44. doi: 10.1016/j.bja.2023.10.012. Epub 2023 Dec 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2017 | Jan 15, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood
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 |
| Toronto Western Hospital | Not yet recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| UMC Utrecht | Recruiting | Utrecht | Netherlands |
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