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Published in: BMC Geriatrics 1/2024

Open Access 01-12-2024 | Study Protocol

Association between preoperative frailty and myocardial injury after noncardiac surgery in geriatric patients: study protocol for a prospective, multicentre, real-world observational, cohort trial

Authors: Yongtao Sun, Na Guo, Min Zhang, Mengjie Liu, Zhongquan Gao, Tao Sun, Xiaojun Gao, Lingling Xu, Haixia Zhang, Chuansong Wei, Peng Liu, Yang Liu, Xiaoning Zhang, Yongle Guo, Lina Chen, Zheng Zhou, Zhenqiang Su, Yanmei Hu, Xin Shi, Linlin Huang, Yuelan Wang

Published in: BMC Geriatrics | Issue 1/2024

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Abstract

Introduction

Frailty has become a worldwide health burden that has a large influence on public health and clinical practice. The incidence of frailty is anticipated to increase as the ageing population increases. Myocardial injury after noncardiac surgery (MINS) is associated with short-term and long-term mortality. However, the incidence of MINS in frail geriatric patients is unknown.

Methods and analysis

This prospective, multicentre, real-world observational cohort study will be conducted at 18 designated centres in China from January 2023 to December 2024, with an anticipated sample size of 856 patients aged 65 years and older who are scheduled to undergo noncardiac surgery. The primary outcome will be the incidence of MINS. MINS is defined as a fourth-generation plasma cardiac troponin T (cTnT) concentration ≥ 0.03 ng/mL exhibited at least once within 30 days after surgery, with or without symptoms of myocardial ischaemia. All data will be collected via electronic data acquisition.

Discussion

This study will explore the incidence of MINS in frail patients. The characteristics, predictive factors and 30-day outcomes of MINS in frail patients will be further investigated to lay the foundation for identifying clinical interventions.

Clinical trial registration

Appendix
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Literature
1.
go back to reference Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–62.CrossRefPubMed Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–62.CrossRefPubMed
2.
go back to reference Brivio P, Paladini MS, Racagni G, Riva MA, Calabrese F, Molteni R. From healthy aging to Frailty: in search of the underlying mechanisms. Curr Med Chem. 2019;26(20):3685–701.CrossRefPubMed Brivio P, Paladini MS, Racagni G, Riva MA, Calabrese F, Molteni R. From healthy aging to Frailty: in search of the underlying mechanisms. Curr Med Chem. 2019;26(20):3685–701.CrossRefPubMed
3.
go back to reference Kulason K, Nouchi R, Hoshikawa Y, Noda M, Okada Y, Kawashima R. Indication of Cognitive Change and Associated Risk factor after thoracic surgery in the Elderly: a pilot study. Front Aging Neurosci. 2017;9:396.CrossRefPubMedPubMedCentral Kulason K, Nouchi R, Hoshikawa Y, Noda M, Okada Y, Kawashima R. Indication of Cognitive Change and Associated Risk factor after thoracic surgery in the Elderly: a pilot study. Front Aging Neurosci. 2017;9:396.CrossRefPubMedPubMedCentral
4.
go back to reference van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, de Jongh MAC. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal study. BMJ Open. 2019;9(7):e025941.CrossRefPubMedPubMedCentral van de Ree CLP, Landers MJF, Kruithof N, de Munter L, Slaets JPJ, Gosens T, de Jongh MAC. Effect of frailty on quality of life in elderly patients after hip fracture: a longitudinal study. BMJ Open. 2019;9(7):e025941.CrossRefPubMedPubMedCentral
5.
go back to reference Johnson RL, Abdel MP, Frank RD, Chamberlain AM, Habermann EB, Mantilla CB. Impact of Frailty on outcomes after primary and revision total hip arthroplasty. J Arthroplasty. 2019;34(1):56–64e55.CrossRefPubMed Johnson RL, Abdel MP, Frank RD, Chamberlain AM, Habermann EB, Mantilla CB. Impact of Frailty on outcomes after primary and revision total hip arthroplasty. J Arthroplasty. 2019;34(1):56–64e55.CrossRefPubMed
6.
go back to reference Khan M, Jehan F, Zeeshan M, Kulvatunyou N, Fain MJ, Saljuqi AT, O’Keeffe T, Joseph B. Failure to rescue after emergency general surgery in geriatric patients: does Frailty Matter? J Surg Res. 2019;233:397–402.CrossRefPubMed Khan M, Jehan F, Zeeshan M, Kulvatunyou N, Fain MJ, Saljuqi AT, O’Keeffe T, Joseph B. Failure to rescue after emergency general surgery in geriatric patients: does Frailty Matter? J Surg Res. 2019;233:397–402.CrossRefPubMed
7.
go back to reference Chappidi MR, Kates M, Patel HD, Tosoian JJ, Kaye DR, Sopko NA, Lascano D, Liu JJ, McKiernan J, Bivalacqua TJ. Frailty as a marker of adverse outcomes in patients with bladder cancer undergoing radical cystectomy. Urol Oncol. 2016;34(6):256e251–256.CrossRef Chappidi MR, Kates M, Patel HD, Tosoian JJ, Kaye DR, Sopko NA, Lascano D, Liu JJ, McKiernan J, Bivalacqua TJ. Frailty as a marker of adverse outcomes in patients with bladder cancer undergoing radical cystectomy. Urol Oncol. 2016;34(6):256e251–256.CrossRef
8.
go back to reference Partridge JS, Fuller M, Harari D, Taylor PR, Martin FC, Dhesi JK. Frailty and poor functional status are common in arterial vascular surgical patients and affect postoperative outcomes. Int J Surg. 2015;18:57–63.CrossRefPubMed Partridge JS, Fuller M, Harari D, Taylor PR, Martin FC, Dhesi JK. Frailty and poor functional status are common in arterial vascular surgical patients and affect postoperative outcomes. Int J Surg. 2015;18:57–63.CrossRefPubMed
9.
go back to reference Parmar KL, Law J, Carter B, Hewitt J, Boyle JM, Casey P, Maitra I, Farrell IS, Pearce L, Moug SJ. Frailty in older patients undergoing emergency laparotomy: results from the UK Observational Emergency Laparotomy and Frailty (ELF) Study. Ann Surg. 2021;273(4):709–18.CrossRefPubMed Parmar KL, Law J, Carter B, Hewitt J, Boyle JM, Casey P, Maitra I, Farrell IS, Pearce L, Moug SJ. Frailty in older patients undergoing emergency laparotomy: results from the UK Observational Emergency Laparotomy and Frailty (ELF) Study. Ann Surg. 2021;273(4):709–18.CrossRefPubMed
10.
go back to reference Muscedere J, Waters B, Varambally A, Bagshaw SM, Boyd JG, Maslove D, Sibley S, Rockwood K. The impact of frailty on intensive care unit outcomes: a systematic review and meta-analysis. Intensive Care Med. 2017;43(8):1105–22.CrossRefPubMedPubMedCentral Muscedere J, Waters B, Varambally A, Bagshaw SM, Boyd JG, Maslove D, Sibley S, Rockwood K. The impact of frailty on intensive care unit outcomes: a systematic review and meta-analysis. Intensive Care Med. 2017;43(8):1105–22.CrossRefPubMedPubMedCentral
11.
go back to reference Puelacher C, Bollen Pinto B, Mills NL, Duceppe E, Popova E, Duma A, Nagele P, Omland T, Hammerer-Lercher A, Lurati Buse G. Expert consensus on peri-operative myocardial injury screening in noncardiac surgery: a literature review. Eur J Anaesthesiol. 2021;38(6):600–8.CrossRefPubMed Puelacher C, Bollen Pinto B, Mills NL, Duceppe E, Popova E, Duma A, Nagele P, Omland T, Hammerer-Lercher A, Lurati Buse G. Expert consensus on peri-operative myocardial injury screening in noncardiac surgery: a literature review. Eur J Anaesthesiol. 2021;38(6):600–8.CrossRefPubMed
12.
go back to reference Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018;44(6):811–22.CrossRefPubMed Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018;44(6):811–22.CrossRefPubMed
13.
go back to reference Botto F, Alonso-Coello P, Chan MT, Villar JC, Xavier D, Srinathan S, Guyatt G, Cruz P, Graham M, Wang CY, et al. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology. 2014;120(3):564–78.CrossRefPubMed Botto F, Alonso-Coello P, Chan MT, Villar JC, Xavier D, Srinathan S, Guyatt G, Cruz P, Graham M, Wang CY, et al. Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes. Anesthesiology. 2014;120(3):564–78.CrossRefPubMed
14.
go back to reference Puelacher C, Lurati Buse G, Seeberger D, Sazgary L, Marbot S, Lampart A, Espinola J, Kindler C, Hammerer A, Seeberger E, et al. Perioperative Myocardial Injury after noncardiac surgery: incidence, mortality, and characterization. Circulation. 2018;137(12):1221–32.CrossRefPubMed Puelacher C, Lurati Buse G, Seeberger D, Sazgary L, Marbot S, Lampart A, Espinola J, Kindler C, Hammerer A, Seeberger E, et al. Perioperative Myocardial Injury after noncardiac surgery: incidence, mortality, and characterization. Circulation. 2018;137(12):1221–32.CrossRefPubMed
15.
go back to reference Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019;40(3):237–69.CrossRefPubMed Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019;40(3):237–69.CrossRefPubMed
16.
go back to reference Kusunose K, Okushi Y, Yamada H, Nishio S, Torii Y, Hirata Y, Saijo Y, Ise T, Yamaguchi K, Yagi S, et al. Prognostic value of Frailty and Diastolic Dysfunction in Elderly patients. Circ J. 2018;82(8):2103–10.CrossRefPubMed Kusunose K, Okushi Y, Yamada H, Nishio S, Torii Y, Hirata Y, Saijo Y, Ise T, Yamaguchi K, Yagi S, et al. Prognostic value of Frailty and Diastolic Dysfunction in Elderly patients. Circ J. 2018;82(8):2103–10.CrossRefPubMed
17.
go back to reference Vidán MT, Blaya-Novakova V, Sánchez E, Ortiz J, Serra-Rexach JA, Bueno H. Prevalence and prognostic impact of frailty and its components in non-dependent elderly patients with heart failure. Eur J Heart Fail. 2016;18(7):869–75.CrossRefPubMed Vidán MT, Blaya-Novakova V, Sánchez E, Ortiz J, Serra-Rexach JA, Bueno H. Prevalence and prognostic impact of frailty and its components in non-dependent elderly patients with heart failure. Eur J Heart Fail. 2016;18(7):869–75.CrossRefPubMed
19.
go back to reference Leibowitz D, Jacobs JM, Gilon D, Lande-Stessman I, Ein-Mor E, Stessman J. Cardiac structure and function and frailty in subjects aged 85 and 86 years. Am J Cardiol. 2016;118(5):760–4.CrossRefPubMed Leibowitz D, Jacobs JM, Gilon D, Lande-Stessman I, Ein-Mor E, Stessman J. Cardiac structure and function and frailty in subjects aged 85 and 86 years. Am J Cardiol. 2016;118(5):760–4.CrossRefPubMed
20.
go back to reference Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, et al. Frailty in older adults: evidence for a phenotype. J Gerontol Biol Sci Med Sci. 2001;56(3):M146–156.CrossRef Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, et al. Frailty in older adults: evidence for a phenotype. J Gerontol Biol Sci Med Sci. 2001;56(3):M146–156.CrossRef
21.
go back to reference Idänpään-Heikkilä JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89–94.CrossRefPubMed Idänpään-Heikkilä JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89–94.CrossRefPubMed
22.
go back to reference World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014;81(3):14–8. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014;81(3):14–8.
23.
go back to reference Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
24.
go back to reference Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):1245–51.CrossRefPubMed Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):1245–51.CrossRefPubMed
25.
go back to reference Subramaniam S, Aalberg JJ, Soriano RP, Divino CM. New 5-Factor modified Frailty Index using American College of Surgeons NSQIP Data. J Am Coll Surg. 2018;226(2):173–181e178.CrossRefPubMed Subramaniam S, Aalberg JJ, Soriano RP, Divino CM. New 5-Factor modified Frailty Index using American College of Surgeons NSQIP Data. J Am Coll Surg. 2018;226(2):173–181e178.CrossRefPubMed
26.
go back to reference Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L value set for China. Value Health. 2017;20(4):662–9.CrossRefPubMed Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L value set for China. Value Health. 2017;20(4):662–9.CrossRefPubMed
27.
go back to reference Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and management of patients with myocardial Injury after noncardiac surgery: a Scientific Statement from the American Heart Association. Circulation. 2021;144(19):e287–e305.CrossRefPubMed Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and management of patients with myocardial Injury after noncardiac surgery: a Scientific Statement from the American Heart Association. Circulation. 2021;144(19):e287–e305.CrossRefPubMed
28.
go back to reference Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: an EQ-5D-5L value set for England. Health Econ. 2018;27(1):7–22.CrossRefPubMed Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: an EQ-5D-5L value set for England. Health Econ. 2018;27(1):7–22.CrossRefPubMed
29.
go back to reference Luo N, Li M, Chevalier J, Lloyd A, Herdman M. A comparison of the scaling properties of the English, Spanish, French, and Chinese EQ-5D descriptive systems. Qual Life Res. 2013;22(8):2237–43.CrossRefPubMed Luo N, Li M, Chevalier J, Lloyd A, Herdman M. A comparison of the scaling properties of the English, Spanish, French, and Chinese EQ-5D descriptive systems. Qual Life Res. 2013;22(8):2237–43.CrossRefPubMed
30.
go back to reference Biccard BM, Scott DJA, Chan MTV, Archbold A, Wang CY, Sigamani A, Urrútia G, Cruz P, Srinathan SK, Szalay D, et al. Myocardial Injury after noncardiac surgery (MINS) in Vascular Surgical patients: a prospective Observational Cohort Study. Ann Surg. 2018;268(2):357–63.CrossRefPubMed Biccard BM, Scott DJA, Chan MTV, Archbold A, Wang CY, Sigamani A, Urrútia G, Cruz P, Srinathan SK, Szalay D, et al. Myocardial Injury after noncardiac surgery (MINS) in Vascular Surgical patients: a prospective Observational Cohort Study. Ann Surg. 2018;268(2):357–63.CrossRefPubMed
31.
go back to reference Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, et al. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012;307(21):2295–304.CrossRefPubMed Devereaux PJ, Chan MT, Alonso-Coello P, Walsh M, Berwanger O, Villar JC, Wang CY, Garutti RI, Jacka MJ, Sigamani A, et al. Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery. JAMA. 2012;307(21):2295–304.CrossRefPubMed
32.
go back to reference Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019;394(10206):1365–75.CrossRefPubMed Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019;394(10206):1365–75.CrossRefPubMed
33.
go back to reference Kojima G, Iliffe S, Jivraj S, Walters K. Association between frailty and quality of life among community-dwelling older people: a systematic review and meta-analysis. J Epidemiol Community Health. 2016;70(7):716–21.CrossRefPubMed Kojima G, Iliffe S, Jivraj S, Walters K. Association between frailty and quality of life among community-dwelling older people: a systematic review and meta-analysis. J Epidemiol Community Health. 2016;70(7):716–21.CrossRefPubMed
34.
go back to reference Saum KU, Dieffenbach AK, Müller H, Holleczek B, Hauer K, Brenner H. Frailty prevalence and 10-year survival in community-dwelling older adults: results from the ESTHER cohort study. Eur J Epidemiol. 2014;29(3):171–9.CrossRefPubMed Saum KU, Dieffenbach AK, Müller H, Holleczek B, Hauer K, Brenner H. Frailty prevalence and 10-year survival in community-dwelling older adults: results from the ESTHER cohort study. Eur J Epidemiol. 2014;29(3):171–9.CrossRefPubMed
35.
go back to reference Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodríguez Monforte M, Bergman H, et al. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017;46(3):383–92.PubMedPubMedCentral Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodríguez Monforte M, Bergman H, et al. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017;46(3):383–92.PubMedPubMedCentral
36.
go back to reference Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, et al. Association of Postoperative High-Sensitivity troponin levels with myocardial Injury and 30-Day mortality among patients undergoing noncardiac surgery. JAMA. 2017;317(16):1642–51.CrossRefPubMed Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, et al. Association of Postoperative High-Sensitivity troponin levels with myocardial Injury and 30-Day mortality among patients undergoing noncardiac surgery. JAMA. 2017;317(16):1642–51.CrossRefPubMed
Metadata
Title
Association between preoperative frailty and myocardial injury after noncardiac surgery in geriatric patients: study protocol for a prospective, multicentre, real-world observational, cohort trial
Authors
Yongtao Sun
Na Guo
Min Zhang
Mengjie Liu
Zhongquan Gao
Tao Sun
Xiaojun Gao
Lingling Xu
Haixia Zhang
Chuansong Wei
Peng Liu
Yang Liu
Xiaoning Zhang
Yongle Guo
Lina Chen
Zheng Zhou
Zhenqiang Su
Yanmei Hu
Xin Shi
Linlin Huang
Yuelan Wang
Publication date
01-12-2024
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2024
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-024-04847-z

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