Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- NT-proBNP blood test measured on the day of (pre-) vascular surgery
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are equal to or over 18 years old
- •Patients scheduled to undergo elective surgery for the following procedures:
- •Infrainguinal arterial reconstruction
- •Aortic aneurysm
- •Aorto-bifemoral bypass / or aortic endarterectomy
- •Femoro-popliteal bypass
- •Femoro-distal bypass
- •Femoral endarterectomy
- •Femoro-femoral crossover
- •Axillo-femoral bypass
- •Elective carotid surgery
- •Patients having either general or regional anaesthesia for their surgery
Exclusion Criteria
- •Patients undergoing emergency surgery
- •Those who are unable or unwilling to give informed consent
- •Patients with unstable coronary syndromes (acute or recent MI with evidence of important ischemic risk by clinical symptoms or stress testing or unstable or severe angina pectoris)
- •Patients with decompensated heart failure (new onset shortness of breath and rales together with echocardiographic evidence of cardiac dysfunction or deterioration of chronic heart failure despite heart failure therapy)
- •Patients with chronic atrial fibrillation
Outcomes
Primary Outcomes
NT-proBNP blood test measured on the day of (pre-) vascular surgery
Time Frame: 4 days
NT-proBNP blood test measured on the day of (pre-) vascular surgery
NT-proBNP blood test measured on the day 4 after (post-) vascular surgery
Time Frame: 4 days
NT-proBNP blood test measured on the day 4 after (post-) vascular surgery
Change in NT-proBNP peri-operatively
Time Frame: 4 days
Change in NT-proBNP peri-operatively
Secondary Outcomes
- Pre-, post-, and peri-operative troponin I(4 days)
- Pre-, post-, and peri-operative galectin-3(4 days)
- Pre-, post-, and peri-operative CRP(4 days)
- Pre-, post-, and peri-operative creatinine(4 days)
Investigators
Julie Dawson
Research Services Manager
Norfolk and Norwich University Hospitals NHS Foundation Trust