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

June 20, 2024 updated by: Jordan Leitch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-centre, prospective study to determine the correlation and comparative thresholds between NT ProBNP (Roche) and BNP (Abbott) tests. This will involve simultaneous serum sampling for both BNP and NT ProBNP at pre-surgical screening (PSS) or on the day of surgery (DOS). Serum sampling of BNP in this patient population is standard of care in our institution, thus only the additional blood required for the NT ProBNP test requires additional consent. Informed consent will be obtained at PSS or on the DOS by study staff. High sensitivity troponin I (Abbott) measurements will be taken on postoperative day (POD) 0, 1 and 2, as per local standard of care and the outcome of MINS (myocardial injury after non-cardiac surgery as indicated by 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. The primary outcome is correlation of POC NT ProBNP with BNP levels and validation of appropriate thresholds. The secondary outcome is combined MINS and vascular death at POD 30.

The study population will include patients assessed in PSS or on the DOS who are presenting for elective surgery requiring a minimum of one-night admission following and 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).

The required sample size of 431 patients was calculated to adequately perform a power assessment of the primary outcome of correlating BNP and NT ProBNP thresholds. Historically, Presurgical Screening (PSS) at Kingston Health Sciences Centre (KHSC) collects BNP serum samples from approximately 500 patients at PSS in a six month time frame, as reported by a local, retrospective quality assurance study (McMullen/Cook). This sample size will not likely be sufficient to determine significance regarding the secondary outcome of MINS or vascular death by POD 30. Nonetheless, the trend observed may be informative in the context of correlating the risk prediction provided by BNP screening at our centre to that from larger studies.

Study Type

Observational

Enrollment (Actual)

466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K0H1S0
        • Kingston Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Age < 18 years
  • Patient undergoing cardiac surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BNP/NT ProBNP Conversion Formula
Time Frame: Within three months before surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
POD30 Myocardial injury after non-cardiac surgery (MINS)
Time Frame: 30 days after surgery
Incidence of thirty-day post-operative myocardial injury after non-cardiac surgery (MINS) as determined by high-sensitivity troponin I (Abbott) > 30 ng/L
30 days after surgery
POD30 Vascular Death
Time Frame: 30 days after surgery
Thirty day vascular death is defined as death from the composite of these vascular diseases: hypertensive disease, ischemic heart disease, cerebrovascular disease, pulmonary vascular disease, renal failure, artery/arteriole/capillary disease.
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan Leitch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6035639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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