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

February 15, 2023 updated by: European Society of Anaesthesiology

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

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?

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing elective, elevated-risk noncardiac surgery.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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).
within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
at 30days after surgery or on discharge
Inhospital all-cause mortality
Time Frame: at 30days after surgery
at 30days after surgery
complications ≥ 3 in Clavien Dindo Classification
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.
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.
length of In hospital stay (days), length of ICU stay (days in the ICU)
Time Frame: from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .
from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .
myocardial injury after noncardiac surgery (MINS)
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Anaesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MET-REPAIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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