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

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ClinicalTrials.gov Identifier: NCT03016936
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
European Society of Anaesthesiology

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?

Condition or disease
Non Cardiac Surgery

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.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR) Observational Multicentre Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2021

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%



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. Inhospital all-cause mortality [ Time Frame: at 30days after surgery ]
  3. 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. ]
  4. 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. . ]
  5. 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


Biospecimen Retention:   Samples With DNA
For the NTproBNP sub-study, 5 ml of blood is sampled. No storage after measurement.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing elective, elevated-risk noncardiac surgery.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016936


Contacts
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Contact: Sylvia Daamen +3222109414 research@esahq.org
Contact: Prisca Feijten +3222266633 research@esahq.org

Locations
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Germany
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Giovanna Lurati Buse, MD         
Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
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Study Chair: Giovanna Lurati Buse, PD Dr. University Hospital, Düsseldorf, Germany
Publications:

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Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT03016936    
Other Study ID Numbers: MET-REPAIR
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by European Society of Anaesthesiology:
Metabolic equivalents (METs)
European Society of Anaesthesiology (ESA)
Noncardiac surgery
Cardiovascular Mortality