Validation of B-type Natriuretic Peptide With N-terminal Pro B-type Natriuretic Peptide in Perioperative Risk Assessment

NCT05352698 | Completed FDA Device

• 1 other identifier: 6035639
• Study Type: observational
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, prospective study to determine the correlation and comparative thresholds between N-terminal pro-brain natriuretic peptide (NT ProBNP, Roche) and brain natriuretic peptide (BNP, Abbott) tests. The study population will include patients assessed in presurgical screening (PSS) or on the day of surgery (DOS) who are presenting for elective surgery requiring a minimum of one-night admission, and are a) \>65 years old, b) RCRI ≥1 or c) \>45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy). Informed consent will be obtained at PSS or on the DOS by study staff. High sensitivity troponin I measurements will be taken on postoperative day (POD) 0, 1 and 2, and the outcome of MINS (high sensitivity troponin \> 30 ng/L) or vascular death will be determined by an assessor blinded to BNP/NT ProBNP results at postoperative day (POD) 30. Given a sample size of 431 patients and based upon previous local data that found approximately 500 patients qualifying for BNP testing in a six month period, the investigators predict data collection to be completed in approximately six months.

Conditions

Perioperative Care

Keywords

BNP; NT ProBNP; MINS; myocardial injury after non-cardiac surgery; perioperative risk; risk stratification; perioperative care

Outcome Measures

Primary Outcomes (1)

• BNP/NT ProBNP Conversion Formula

  The primary objective of this study is to determine external validation of the BNP (Abbott)/NT ProBNP conversion formula (Kasahara et al., 2019) and to provide recalibration, if necessary, for the POC NT ProBNP results.

  Within three months before surgery

Secondary Outcomes (2)

• POD30 Myocardial injury after non-cardiac surgery (MINS)

  30 days after surgery

• POD30 Vascular Death

  30 days after surgery

Study Arms (1)

Non-Cardiac Surgery Patient

Our study population will be comprised of any patient undergoing non-cardiac surgery who meets standard of care criteria for BNP testing. This includes patients who are a) \>65 years old, b) revised cardiac risk index (RCRI) ≥1 or c) \>45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy)

Diagnostic Test: NT ProBNP (Roche)

Interventions

NT ProBNP (Roche) DIAGNOSTIC_TEST

This NT ProBNP assay is a point-of-care (POC) test that will be conducted on a 2 mL sample of whole blood collected in a non-heparinized tube. NT ProBNP results are used in this setting to predict perioperative cardiovascular risk.

Non-Cardiac Surgery Patient

Eligibility Criteria

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

Study Population

The study population will include patients assessed in pre-surgical screening or on the day of surgery who are presenting for non-cardiac surgery requiring a minimum of one-night admission following and are a) \>65 years old, b) RCRI ≥1 or c) \>45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy).

You may qualify if:

• Patient consents to study and is undergoing non-cardiac surgery and is one of:
• Age \> 65 years
• Revised cardiac risk index (RCRI) \>=1
• Age \> 45 years old with significant cardiovascular disease (coronary artery disease, peripheral arterial disease, cerebral vascular disease, congestive heart failure, obstructive intracardiac disease such as severe aortic stenosis, severe mitral stenosis or severe hypertrophic obstructive cardiomyopathy)

You may not qualify if:

• Age \< 18 years
• Patient undergoing cardiac surgery

Sponsors & Collaborators

• Jordan Leitch: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K0H1S0, Canada

Location

Related Publications (15)

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  PMID: 24534856 RESULT

• Davidson T, Parlow J, King B, DuMerton D, Roshanov PS, Devereaux PJ, Leitch J. Conversion between B-type natriuretic peptide and N-terminal pro B-type natriuretic peptide in perioperative risk assessment: protocol for a prospective cohort study. BMJ Open. 2023 May 19;13(5):e068147. doi: 10.1136/bmjopen-2022-068147.

  PMID: 37208131 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 29, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CA (1)