Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Location status: Recruiting
Location contact
Allison Chipchase, Dr
CONTACT
Emma Miler
CONTACT
NCT Number: NCT04014647
The team is investigating whether N-terminal pro B-type natriuretic peptide (NT-proBNP) and other cardiac markers are useful for predicting outcomes for patients undergoing vascular surgery. By measuring NT-proBNP before and after surgery, the investigators may be able to determine which patients are at risk of an adverse outcome, such as a heart attack or death.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Norwich, Norfolk, NR4 7UY, United Kingdom
Location status: Recruiting
Allison Chipchase, Dr
CONTACT
Emma Miler
CONTACT
Almost 1 in 5 patients who have elective major vascular surgery experience death or a myocardial infarction (MI) at 18 months post-surgery. Research has shown that peri-operative interventions may improve outcomes for high-risk patients. Cardiac bio-markers may be used to identify these high-risk patients, in particular pre- and post-operative NT-proBNP.
Mahla found that by comparing surgery outcomes with NT-proBNP concentrations peri-operatively, high-risk patients could be identified and subsequent therapeutic decisions could be made to minimise adverse outcomes.
Van Kimmenade evaluated patients with acute heart failure and found that galectin-3 (Gal-3) was the best predictor of 60-day mortality compared with NT-proBNP and apelin (another cardiac marker), whereas NT-proBNP was the most useful for diagnosing HF. The authors also found that the combination of both markers (Gal-3 and NT-proBNP) have an even higher predictive value for outcome.
The predictive role of troponin I (cTnI) has been observed in a paper by Bursi et al. (2005) where patients undergoing elective major vascular surgery were stratified using the American College of Cardiology/American Heart Association (ACC/AHA) guidelines and followed up over a period of 24 months. Patients in every group with an elevated post-operative cTnI (≥100ng/L) were at greater risk of either MI or death.
The successful identification of high-risk patients can go on to have interventional risk-reducing pharmacological, therapeutic, diagnostic, or observational measures.
Prevention of cardiovascular events, particular for an aging population, can have positive impact on both the patient and society as a whole as it may result in patients maintaining their independence, avoiding major illness, avoiding nursing home care and living longer.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Time frame: 4 days
NT-proBNP blood test measured on the day of (pre-) vascular surgery
Time frame: 4 days
NT-proBNP blood test measured on the day 4 after (post-) vascular surgery
Time frame: 4 days
Change in NT-proBNP peri-operatively
Time frame: 4 days
Pre-, post-, and peri-operative troponin I
Time frame: 4 days
Pre-, post-, and peri-operative galectin-3
Time frame: 4 days
Pre-, post-, and peri-operative CRP
Time frame: 4 days
Pre-, post-, and peri-operative creatinine
Contact information is provided by the study sponsor or research team.
Allison Chipchase, Dr
CONTACT
Emma Miler, MSc BSc Hons
CONTACT
Norfolk and Norwich University Hospitals NHS Foundation Trust
Other
Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
Acronym: MOBOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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