Vascular Surgical Procedure
Conditions
Keywords
Vascular Surgical Procedure, Pro-brain natriuretic peptide (1-76), Natriuretic Peptide, Brain, Troponin I, Galectin 3, Biomarkers, Risk
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. 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.
Interventions
None listed
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP blood test measured on the day of (pre-) vascular surgery | 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 | 4 days | NT-proBNP blood test measured on the day 4 after (post-) vascular surgery |
| Change in NT-proBNP peri-operatively | 4 days | Change in NT-proBNP peri-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-, post-, and peri-operative troponin I | 4 days | Pre-, post-, and peri-operative troponin I |
| Pre-, post-, and peri-operative galectin-3 | 4 days | Pre-, post-, and peri-operative galectin-3 |
| Pre-, post-, and peri-operative CRP | 4 days | Pre-, post-, and peri-operative CRP |
| Pre-, post-, and peri-operative creatinine | 4 days | Pre-, post-, and peri-operative creatinine |
Countries
United Kingdom
Contacts
CONTACTEmma Miler, MSc BSc Hons
CONTACTAllison Chipchase, Dr
PRINCIPAL_INVESTIGATOREmma Miler, MSc BSc Hons
principle investigator
Outcome results
None listed