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

NCT03016936 | Completed

• 1 other identifier: MET-REPAIR
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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. 1.What is the optimal cut-off for METs estimated by questionnaire to predict perioperative major adverse cardiovascular events or cardiovascular mortality?
2. 2.How does the optimal cut-off compare with the currently guideline-endorsed 4-MET cut-off?

Conditions

Non Cardiac Surgery

Keywords

Metabolic equivalents (METs); European Society of Anaesthesiology (ESA); Noncardiac surgery; Cardiovascular Mortality

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (5)

• 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)

  at 30days after surgery or on discharge

• Inhospital all-cause mortality

  at 30days after surgery

• complications ≥ 3 in Clavien Dindo Classification

  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)

  from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .

• myocardial injury after noncardiac surgery (MINS)

  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.

Study Arms (1)

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%

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing elective, elevated-risk noncardiac surgery.

You may qualify if:

• Planned as Inpatients after surgery
• 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% \[10\]
• years of age or older and undergoing intermediate or high-risk procedures \[3\]
• Signed Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (1)

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Related Publications (12)

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

  PMID: 22998715 BACKGROUND

• Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

  PMID: 24679062 BACKGROUND

• Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.

  PMID: 25127426 BACKGROUND

• Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, Hert SD, Ford I, Gonzalez-Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luscher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Sousa-Uva M, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur Heart J. 2014 Sep 14;35(35):2383-431. doi: 10.1093/eurheartj/ehu282. Epub 2014 Aug 1. No abstract available.

  PMID: 25086026 BACKGROUND

• Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.

  PMID: 25091544 BACKGROUND

• Holtermann A, Marott JL, Gyntelberg F, Sogaard K, Mortensen OS, Prescott E, Schnohr P. Self-reported cardiorespiratory fitness: prediction and classification of risk of cardiovascular disease mortality and longevity--a prospective investigation in the Copenhagen City Heart Study. J Am Heart Assoc. 2015 Jan 27;4(1):e001495. doi: 10.1161/JAHA.114.001495.

  PMID: 25628408 BACKGROUND

• Stamatakis E, Hamer M, O'Donovan G, Batty GD, Kivimaki M. A non-exercise testing method for estimating cardiorespiratory fitness: associations with all-cause and cardiovascular mortality in a pooled analysis of eight population-based cohorts. Eur Heart J. 2013 Mar;34(10):750-8. doi: 10.1093/eurheartj/ehs097. Epub 2012 May 3.

  PMID: 22555215 BACKGROUND

• Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.

  PMID: 10477528 BACKGROUND

• Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.

  PMID: 21730309 BACKGROUND

• Stroda A, Sulot T, Roth S, M'Pembele R, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Filipovic M, Beck Schimmer B, Spadaro S, Matute P, Turhan SC, van Waes J, Lagarto F, Theodoraki K, Gupta A, Gillmann HJ, Guzzetti L, Kotfis K, Larmann J, Corneci D, Howell SJ, Lurati Buse G; and the MET-REPAIR investigators. Factors affecting adherence to recommendations on pre-operative cardiac testing: A cohort study. Eur J Anaesthesiol. 2024 Sep 1;41(9):695-704. doi: 10.1097/EJA.0000000000002039. Epub 2024 Jul 10.

  PMID: 38988248 DERIVED

• Lurati Buse G, Larmann J, Gillmann HJ, Kotfis K, Ganter MT, Bolliger D, Filipovic M, Guzzetti L, Chammartin F, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Beck-Schimmer B, Howell SJ; METREPAIR NTproBNP Subcohort Investigators. NT-proBNP or Self-Reported Functional Capacity in Estimating Risk of Cardiovascular Events After Noncardiac Surgery. JAMA Netw Open. 2023 Nov 1;6(11):e2342527. doi: 10.1001/jamanetworkopen.2023.42527.

  PMID: 37938844 DERIVED

• Lurati Buse GA, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Filipovic M, Beck-Schimmer B, Spadaro S, Matute P, Bolliger D, Turhan SC, van Waes J, Lagarto F, Theodoraki K, Gupta A, Gillmann HJ, Guzzetti L, Kotfis K, Wulf H, Larmann J, Corneci D, Chammartin-Basnet F, Howell SJ; MET: Reevaluation for Perioperative Cardiac Risk investigators; European Society of Anaesthesiology and Intensive Care. Risk assessment for major adverse cardiovascular events after noncardiac surgery using self-reported functional capacity: international prospective cohort study. Br J Anaesth. 2023 Jun;130(6):655-665. doi: 10.1016/j.bja.2023.02.030. Epub 2023 Apr 1.

  PMID: 37012173 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

For the NTproBNP sub-study, 5 ml of blood is sampled. No storage after measurement.

Study Officials

• Giovanna Lurati Buse, PD Dr.

  Heinrich-Heine University, Duesseldorf

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: January 11, 2017
• Study Start: August 1, 2017
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)