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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-03-30

Brief Summary

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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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Detailed Description

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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

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Non Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subgroup for NTproBNP Substudy

Planned subgroup analyses in patients undergoing vascular, orthopaedic, thoracic surgery, and in patients aged 65 years or older with a RCRI \<2 and NSQIP- MICA \<1%

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No