Measurement Of NT-proBNP to Predict Outcomes in Surgery

Vascular Surgical Procedure Clinical Trial

— MOBOS  

Official title:

Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04014647
• Other study ID #: 260029 (34-03-19)
• Status: Suspended
• Start date: September 5, 2019
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2023
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Surgical Procedure

Locations

Country	Name	City	State
United Kingdom	Norfolk & Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Julie Dawson

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Augoustides J, Fleisher LA. Advancing perioperative prediction of cardiac risk after vascular surgery: does postoperative N-terminal pro-brain natriuretic peptide do the trick? Anesthesiology. 2007 Jun;106(6):1080-2. doi: 10.1097/01.anes.0000267586.04132.65. No abstract available. — View Citation

Bursi F, Babuin L, Barbieri A, Politi L, Zennaro M, Grimaldi T, Rumolo A, Gargiulo M, Stella A, Modena MG, Jaffe AS. Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation. Eur Heart J. 2005 Nov;26(22):2448-56. doi: 10.1093/eurheartj/ehi430. Epub 2005 Jul 29. — View Citation

Canavan M, Smyth A, Robinson SM, Gibson I, Costello C, O'Keeffe ST, Walsh T, Mulkerrin EC, O'Donnell MJ. Attitudes to outcomes measured in clinical trials of cardiovascular prevention. QJM. 2016 Jun;109(6):391-7. doi: 10.1093/qjmed/hcv132. Epub 2015 Jul 31. — View Citation

Feringa HH, Schouten O, Dunkelgrun M, Bax JJ, Boersma E, Elhendy A, de Jonge R, Karagiannis SE, Vidakovic R, Poldermans D. Plasma N-terminal pro-B-type natriuretic peptide as long-term prognostic marker after major vascular surgery. Heart. 2007 Feb;93(2):226-31. doi: 10.1136/hrt.2006.093716. Epub 2006 Aug 16. — View Citation

Mahla E, Baumann A, Rehak P, Watzinger N, Vicenzi MN, Maier R, Tiesenhausen K, Metzler H, Toller W. N-terminal pro-brain natriuretic peptide identifies patients at high risk for adverse cardiac outcome after vascular surgery. Anesthesiology. 2007 Jun;106(6):1088-95. doi: 10.1097/01.anes.0000267591.34626.b0. — View Citation

van Kimmenade RR, Januzzi JL Jr, Ellinor PT, Sharma UC, Bakker JA, Low AF, Martinez A, Crijns HJ, MacRae CA, Menheere PP, Pinto YM. Utility of amino-terminal pro-brain natriuretic peptide, galectin-3, and apelin for the evaluation of patients with acute heart failure. J Am Coll Cardiol. 2006 Sep 19;48(6):1217-24. doi: 10.1016/j.jacc.2006.03.061. Epub 2006 Aug 28. — View Citation

Yeh HM, Lau HP, Lin JM, Sun WZ, Wang MJ, Lai LP. Preoperative plasma N-terminal pro-brain natriuretic peptide as a marker of cardiac risk in patients undergoing elective non-cardiac surgery. Br J Surg. 2005 Aug;92(8):1041-5. doi: 10.1002/bjs.4947. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP blood test measured on the day of (pre-) vascular surgery	NT-proBNP blood test measured on the day of (pre-) vascular surgery	4 days
Primary	NT-proBNP blood test measured on the day 4 after (post-) vascular surgery	NT-proBNP blood test measured on the day 4 after (post-) vascular surgery	4 days
Primary	Change in NT-proBNP peri-operatively	Change in NT-proBNP peri-operatively	4 days
Secondary	Pre-, post-, and peri-operative troponin I	Pre-, post-, and peri-operative troponin I	4 days
Secondary	Pre-, post-, and peri-operative galectin-3	Pre-, post-, and peri-operative galectin-3	4 days
Secondary	Pre-, post-, and peri-operative CRP	Pre-, post-, and peri-operative CRP	4 days
Secondary	Pre-, post-, and peri-operative creatinine	Pre-, post-, and peri-operative creatinine	4 days