NCT03016936

MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR)

MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR) Observational Multicentre Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (actual)
• Sponsor: European Society of Anaesthesiology · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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?

Detailed 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.

Conditions

• Non Cardiac Surgery

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2017-01-11
• Last updated: 2023-02-16

Locations

1 site across 1 country: Germany