Preoperative BNP: Epidemiological Patterns, Management Strategies and Cost Analysis of Care

NCT04077294 | Completed

• 1 other identifier: Pro00086046
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, the use of preoperative BNP as a preoperative risk stratifcation tool was added to the Canadian Cardiovascular Society (CCS) guidelines (4) on perioperative cardiac risk assessment and management for patients who undergo noncardiac surgery, based on the prognostic value of preoperative BNP in indentifiy patients at significant risk of 30-day mortality, nonfatal myocardial infarction, or myocardial injury after noncardiac surgery (MINS). While the value of screening for high risk patients through the use of preoperative BNP been demonstrated, the management of postoperative ischemia is less clear. Therefore, this study aims to:

1. 1.Evaluation of the use of BNP as a preoperative screening biomarker; how often is it ordered in Anesthesia Preadmission Clinic and what is the incidence of a positive result (BNP ≥ 92 ng/L)
2. 2.Determine the incidence of myocardial injury after non-cardiac surgery (MINS) at 30 days and myocardial infarction at 1 year at a tertiary care center when BNP is used as a screening tool
3. 3.Record patterns of management of patients with MINS
4. 4.Determine the cost associated with the different patterns of management of MINS
5. 5.Comparison with a cohort group who qualified for BNP screening according to CCS guidelines but did not have it measured. The investigators will attempt to evaluate the cohort group for MINS at 30 days and myocardial infarction at 1 year.

Conditions

Myocardial Infarction Postoperative; Myocardial Injury; Death, Cardiac

Keywords

Preoperative BNP; Perioperative cardiac risk stratification; Myocardial injury after non-cardiac surgery (MINS); Canadian Cardiovascular Society (CCS) guidelines

Outcome Measures

Primary Outcomes (4)

• Preoperative Brain natriuretic peptide (BNP) ≥ 92 ng/L

  Number of participants with preoperative BNP ≥ 92 ng/L

  From date of preoperative consultation up to the day of surgery, assessed up to 6 months.

• Postoperative troponin I ≥ 0.04 ug / L

  Incidence of myocardial injury in the early postoperative period after non-cardiac surgery (MINS)

  From the end of the surgical procedure to 72 hours postoperatively

• Myocardial injury at 30 days after surgery

  Incidence of myocardial injury 30 days after surgery at risk in patients as determined by preoperative BNP measurement

  30 days after surgery

• Myocardial injury 1 year after surgery

  Incidence of myocardial injury 1 year after surgery at risk in patients as determined by preoperative BNP measurement

  1 year after surgery

Secondary Outcomes (2)

• Observation of management patterns 30 days after surgery in patients with myocardial injury after non-cardiac surgery (MINS)

  30 days after surgery

• Observation of management patterns 1 year after surgery in patients with myocardial injury after non-cardiac surgery (MINS)

  1 year after surgery

Study Arms (2)

Preoperative BNP used for cardiac risk stratification

Cohort of patients recruited in the pre-admission clinic who qualified for, and underwent, preoperative BNP screening according to CCS guidelines.

Other: Cardiac risk stratification using preoperative BNP measurement, followed by postoperative cardiac monitoring

Preoperative BNP not used for cardiac risk stratification

Cohort of patients from patient care database (SPOR) who qualified for preoperative BNP screening according to CCS guidelines, but did not receive screening due to surgery occurring before the implementation of the CCS guidelines.

Other: Use of traditional perioperative cardiac risk stratification only

Interventions

Cardiac risk stratification using preoperative BNP measurement, followed by postoperative cardiac monitoring OTHER

Patients undergoing non-cardiac surgery risk stratified using BNP measurements according to CCS guidelines.

Preoperative BNP used for cardiac risk stratification

Use of traditional perioperative cardiac risk stratification only OTHER

Patients undergoing non-cardiac surgery risk stratified using tools other than BNP measurement such as revised cardiac risk index (RCRI).

Preoperative BNP not used for cardiac risk stratification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients undergoing elective non-cardiac surgery with an overnight hospital stay meeting one of the following criteria: 1. age ≥ 65 2. a revised cardiac risk index (RCRI) ≥ 1 (see Appendix 1) 3. age 45 - 64 with significant cardiovascular disease\* Patients will be identified and recruited in the anesthesia preadmission clinic prior to surgery. \*Known history of coronary artery disease, cerebral vascular disease, peripheral artery disease, congestive heart failure, severe PHTN or a severe obstructive intracardiac abnormality (eg, severe aortic stenosis, severe mitral stenosis, or severe hypertrophic obstructive cardiomyopathy).

You may qualify if:

• All adult patients:
• ≥ 65 years of age
• ≥ 18 years of age with a revised cardiac risk index (RCRI) ≥ 1
• between 45 and 64 years of age with significant cardiovascular disease
• Elective non-cardiac surgery with an overnight hospital stay (minimum 1 day)

You may not qualify if:

• Subjects \< 18 years of age
• Patient refusal to participate
• Patients undergoing cardiac surgery
• Patients undergoing day surgery (\< 1day hospital admission)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital Pre-Admission Clinic

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (9)

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  PMID: 24534856 BACKGROUND

• Udeh BL, Dalton JE, Hata JS, Udeh CI, Sessler DI. Economic trends from 2003 to 2010 for perioperative myocardial infarction: a retrospective, cohort study. Anesthesiology. 2014 Jul;121(1):36-45. doi: 10.1097/ALN.0000000000000233.

  PMID: 24662375 BACKGROUND

• van Waes JA, Nathoe HM, de Graaff JC, Kemperman H, de Borst GJ, Peelen LM, van Klei WA; Cardiac Health After Surgery (CHASE) Investigators. Myocardial injury after noncardiac surgery and its association with short-term mortality. Circulation. 2013 Jun 11;127(23):2264-71. doi: 10.1161/CIRCULATIONAHA.113.002128. Epub 2013 May 10.

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• Duceppe E, Parlow J, MacDonald P, Lyons K, McMullen M, Srinathan S, Graham M, Tandon V, Styles K, Bessissow A, Sessler DI, Bryson G, Devereaux PJ. Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment and Management for Patients Who Undergo Noncardiac Surgery. Can J Cardiol. 2017 Jan;33(1):17-32. doi: 10.1016/j.cjca.2016.09.008. Epub 2016 Oct 4.

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• Rodseth RN, Biccard BM, Le Manach Y, Sessler DI, Lurati Buse GA, Thabane L, Schutt RC, Bolliger D, Cagini L, Cardinale D, Chong CP, Chu R, Cnotliwy M, Di Somma S, Fahrner R, Lim WK, Mahla E, Manikandan R, Puma F, Pyun WB, Radovic M, Rajagopalan S, Suttie S, Vanniyasingam T, van Gaal WJ, Waliszek M, Devereaux PJ. The prognostic value of pre-operative and post-operative B-type natriuretic peptides in patients undergoing noncardiac surgery: B-type natriuretic peptide and N-terminal fragment of pro-B-type natriuretic peptide: a systematic review and individual patient data meta-analysis. J Am Coll Cardiol. 2014 Jan 21;63(2):170-80. doi: 10.1016/j.jacc.2013.08.1630. Epub 2013 Sep 26.

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• Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8.

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• Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

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MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Derek Dillane, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: September 4, 2019
• Study Start: May 21, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)