Validation of B-type Natriuretic Peptide With N-terminal Pro B-type Natriuretic Peptide in Periop… (NCT05352698) | Clinical Trial Compass
CompletedNot Applicable
Validation of B-type Natriuretic Peptide With N-terminal Pro B-type Natriuretic Peptide in Perioperative Risk Assessment
Canada466 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was looking at a formula to convert between two different heart-stress markers — BNP and NT-proBNP — before surgery. Could you explain how these markers are currently used to assess my heart risk before an operation, and whether both tests are available at this hospital?
2Since this study is now completed, have its findings about converting between BNP and NT-proBNP measurements changed how your team evaluates patients like me before surgery?
3If my pre-surgical workup includes one of these heart markers, how does my result influence the decisions made about whether and how safely to proceed with my operation?
4This was a validation study, not a treatment trial — it was testing a measurement tool rather than a new therapy. Given that, how does better accuracy in these heart-stress markers actually translate into a safer or different experience for me as a patient?
5Are there situations where you might order both BNP and NT-proBNP tests, or is one preferred here, and does the conversion formula this study validated affect which one you'd rely on for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.