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

NCT05352698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 466

Last updated 2024-06-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jordan Leitch

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352698 on ClinicalTrials.gov