Clinical trial NCT03016936: MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR)
Official title: MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR) Observational Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Cardiac Surgery
Keywords: Metabolic equivalents (METs)
European Society of Anaesthesiology (ESA)
Noncardiac surgery
Cardiovascular Mortality
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 15000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing elective, elevated-risk noncardiac surgery.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Planned as Inpatients after surgery
* 45 years of age or older AND undergoing elective elevated-risk noncardiac surgery as defined by either a Revised Cardiac Risk Index ≥ 2 \[9\] OR NSQIP MICA\>1% \[10\]
* 65 years of age or older and undergoing intermediate or high-risk procedures \[3\]
* Signed Written informed consent

Exclusion Criteria:

* Non-elective surgery, i.e. planned to occur ≤ 72 hours after diagnosis of the acute condition that makes the procedure necessary
* Acute coronary syndrome or uncontrolled congestive heart failure within the last 30 days of planned day of surgery
* Stroke within the last 7 days of planned day of surgery
* Outpatients
* Patients unable to perform ambulation due to congenital or longstanding illnesses/states (e.g. paraplegics, polio, etc; but explicitly not patients with fractures, needing hip replacement, etc.)
* Unable to consent or unwilling to participate
* Previous enrolment in MET REPAIR (in case of repeated surgery)

Primary outcomes:
measure: Composite of intra or postoperative inhospital cardiovascular mortality, nonfatal cardiac arrest, acute myocardial infarction, stroke and congestive heart failure requiring transfer to a higher care unit or prolonging stay on ICU/intermediate care (≥24h)
timeFrame: within 24 hours after surgery
Secondary outcomes:
measure: 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/IMC (≥24h)
timeFrame: at 30days after surgery or on discharge
measure: Inhospital all-cause mortality
timeFrame: at 30days after surgery
measure: complications ≥ 3 in Clavien Dindo Classification
timeFrame: 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.
measure: length of In hospital stay (days), length of ICU stay (days in the ICU)
timeFrame: from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .
measure: myocardial injury after noncardiac surgery (MINS)
timeFrame: 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.
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Giovanna Lurati Buse, PD Dr.
role: STUDY_CHAIR
References:
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