Non Cardiac SurgeryMET-REPAIRNCT03016936
MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR)
An observational study of Non Cardiac Surgery, run by European Society of Anaesthesiology at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Non Cardiac Surgery
- How many people
- 15,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing elective, elevated-risk noncardiac surgery.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- What is the optimal cut-off for METs estimated by questionnaire to predict perioperative major adverse cardiovascular events or cardiovascular mortality?
- How does the optimal cut-off compare with the currently guideline-endorsed 4-MET cut-off?
Read the 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.
- Conditions
- Non Cardiac Surgery
- Keywords
- Metabolic equivalents (METs), European Society of Anaesthesiology (ESA), Noncardiac surgery, Cardiovascular Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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)
Measured: at 30days after surgery or on discharge
Inhospital all-cause mortality
Measured: at 30days after surgery
complications ≥ 3 in Clavien Dindo Classification
Measured: 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)
Measured: from date of surgery until discharge or until day 30 after surgery, whichever occurs first. .
myocardial injury after noncardiac surgery (MINS)
Only applicable for patients from centres routinely implementing a perioperative troponin screening
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Aug 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Non Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Lurati Buse, PD Dr., Study chair, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016936
- Sponsor's protocol ID
- MET-REPAIR
- Acronym
- MET-REPAIR
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 22998715Devereaux 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.
PubMed 24679062Kristensen 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.
PubMed 25127426Kristensen 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.
PubMed 25086026Fleisher 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.
PubMed 25091544Holtermann 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.
PubMed 25628408Stamatakis 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.
PubMed 22555215Lee 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.
PubMed 10477528Gupta 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.
PubMed 21730309Stroda 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.
PubMed 38988248Stroda A, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Filipovic M, Beck Schimmer B, Spadaro S, Matute P, Ganter MT, Ovezov A, Turhan SC, van Waes J, Lagarto F, Theodoraki K, Gupta A, Gillmann HJ, Guzzetti L, Kotfis K, Larmann J, Corneci D, Buggy DJ, Howell SJ, Lurati Buse G; MET-REPAIR investigators. Pathological findings associated with the updated European Society of Cardiology 2022 guidelines for preoperative cardiac testing: an observational cohort modelling study. Br J Anaesth. 2024 Apr;132(4):675-684. doi: 10.1016/j.bja.2023.12.036. Epub 2024 Feb 9.
PubMed 38336516Lurati 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.
PubMed 37938844Lurati 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.
PubMed 37012173
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MET: REevaluation for Perioperative cArdIac Risk (MET-REPAIR) Observational Multicentre Study
- ClinicalTrials.gov ID
- NCT03016936
- Acronym / sponsor ID
- MET-REPAIR / MET-REPAIR
- Conditions
- Non Cardiac Surgery
- Keywords
- Metabolic equivalents (METs), European Society of Anaesthesiology (ESA), Noncardiac surgery, Cardiovascular Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the optimal cut-off for METs estimated by questionnaire to predict perioperative major adverse cardiovascular events or cardiovascular mortality?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective, elevated-risk noncardiac surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
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
Inhospital all-cause mortality
Time frame: 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.
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. .
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 22998715Pearse 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.
- Background: PubMed 24679062Devereaux 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.
- Background: PubMed 25127426Kristensen 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.
- Background: PubMed 25086026Kristensen 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.
- Background: PubMed 25091544Fleisher 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.
- Background: PubMed 25628408Holtermann 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.
- Background: PubMed 22555215Stamatakis 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.
- Background: PubMed 10477528Lee 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.
- Background: PubMed 21730309Gupta 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.
- Derived from this study: PubMed 38988248Stroda 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.
- Derived from this study: PubMed 38336516Stroda A, Mauermann E, Ionescu D, Szczeklik W, De Hert S, Filipovic M, Beck Schimmer B, Spadaro S, Matute P, Ganter MT, Ovezov A, Turhan SC, van Waes J, Lagarto F, Theodoraki K, Gupta A, Gillmann HJ, Guzzetti L, Kotfis K, Larmann J, Corneci D, Buggy DJ, Howell SJ, Lurati Buse G; MET-REPAIR investigators. Pathological findings associated with the updated European Society of Cardiology 2022 guidelines for preoperative cardiac testing: an observational cohort modelling study. Br J Anaesth. 2024 Apr;132(4):675-684. doi: 10.1016/j.bja.2023.12.036. Epub 2024 Feb 9.
- Derived from this study: PubMed 37938844Lurati 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Lurati Buse, PD Dr. study chair
Heinrich-Heine University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Cardiac Surgery, run by European Society of Anaesthesiology at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016936, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.