Universitätsklinikum Düsseldorf
Düsseldorf, Germany
NCT Number: NCT03016936
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?
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Notify Me45 year and older
All sexes
Observational
Düsseldorf, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 24 hours after surgery
Composite of intra- or postoperative inhospital cardiovascular mortality, nonfatal cardiac arrest, acute myocardial infarction, stroke, and congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h).
Time frame: at 30days after surgery or on discharge
composite of intra- or postoperative inhospital cardiovascular mortality, nonfatal cardiac arrest, acute myocardial infarction, stroke, and congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)
Time frame: at 30days after surgery
Time frame: From date of surgery until up to day 30 after surgery or until discharge if occurred before day 30 and no follow-up call is carried out.
Time frame: from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .
Time frame: From date of surgery until up to day 30 after surgery or until discharge if occurred before day 30 and no follow-up call is carried out.
Only applicable for patients from centres routinely implementing a perioperative troponin screening
European Society of Anaesthesiology
Other
MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR) Observational Multicentre Study
Acronym: MET-REPAIR
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