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Clinical Trial Summary

Multicentre international prospective cohort study designed to answer the question: "In patients undergoing elevated risk noncardiac surgery, are METs estimated by questionnaire associated with perioperative major adverse cardiovascular events or cardiovascular mortality?" If so: 1. What is the optimal cut-off for METs estimated by questionnaire to predict perioperative major adverse cardiovascular events or cardiovascular mortality? 2. How does the optimal cut-off compare with the currently guideline-endorsed 4-MET cut-off?


Clinical Trial Description

In spite of scarce and non-conclusive evidence on the prognostic value of self-reported functional capacity for perioperative cardiovascular events, the estimation of cardiovascular functional capacity in metabolic equivalents (METs) based on a questionnaire represent the core question in the preoperative cardiac risk assessment in patients undergoing elevated risk noncardiac surgery endorsed by ESA, the ESC, and the ACC/AHA. MET-REPAIR will examine the ability of MET estimated using a questionnaire to predict perioperative cardiovascular events correcting for preoperative risk factors, (e.g. comorbidity and type of surgery) and calculate the effect on risk stratification (net reclassification improvement) by the addition of METs estimated by questionnaire to established risk scores, such as the Revised Cardiac Risk Score (Lee-index) and the NSQIP MICA . Further, investigators will address alternative approaches to functional capacity estimation (1. ability to climb stairs; 2. self-assessed functional capacity compared to peers; 3. Daily/weekly physical activity) and their predictive value for perioperative cardiovascular events. The association between elevated natriuretic peptides prior to noncardiac surgery and perioperative cardiovascular events is well established. However, a direct comparison of the predictive ability of biomarkers vs. self-reported MET is lacking. Therefore, in a substudy (NTproBNP substudy), investigators will evaluate in how far the addition of NTproBNP improve prediction of perioperative cardiovascular events and cardiovascular mortality when added to clinical data and estimated METs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03016936
Study type Observational
Source European Society of Anaesthesiology
Contact
Status Completed
Phase
Start date August 1, 2017
Completion date March 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT00336401 - Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery Phase 4
Recruiting NCT03489486 - Presepsin (sCD14-ST) for Prediction of Perioperative Risk - MET-REPAIR Nested Cohort Study