Vascular Surgical ProcedureMOBOSNCT04014647
Measurement Of NT-proBNP to Predict Outcomes in Surgery
An observational study of Vascular Surgical Procedure, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Surgical Procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2019to 5 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred to have vascular surgery
Who may be able to join
- 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
Show all 12Show fewer
- Femoro-distal bypass
- Femoral endarterectomy
- Femoro-femoral crossover
- Axillo-femoral bypass
- Elective carotid surgery
- Patients having either general or regional anaesthesia for their surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
Allison Chipchase, Dr, +44 1603 287945, allison/chipchase@nnuh.nhs.uk
Emma Miler, +44 1603 286392, emma.miler@nnuh.nhs.uk
About this study
Official title: Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
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.
Read the 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.
- Conditions
- Vascular Surgical Procedure
- Keywords
- Vascular Surgical Procedure, Pro-brain natriuretic peptide (1-76), Natriuretic Peptide, Brain, Troponin I, Galectin 3, Biomarkers, Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Event-free | Patients who have had no negative events (as described in group 2) | |
| Negative event | Group 2 - patients with one or more of the following negative events post-operatively: * Whether the patient has been prescribed inotropic support * Wound infection by assessing use of antibiotics. * Length of stay in hospital >1 week * Reduced renal function assessed by having any AKI alert during hospital stay * Cardiac event within 31 days following surgery * Death within 31 days following surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP blood test measured on the day of (pre-) vascular surgery
NT-proBNP blood test measured on the day of (pre-) vascular surgery
Measured: 4 days
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
Measured: 4 days
Change in NT-proBNP peri-operatively
Change in NT-proBNP peri-operatively
Measured: 4 days
Secondary outcomes (4)
Pre-, post-, and peri-operative troponin I
Pre-, post-, and peri-operative troponin I
Measured: 4 days
Pre-, post-, and peri-operative galectin-3
Pre-, post-, and peri-operative galectin-3
Measured: 4 days
Pre-, post-, and peri-operative CRP
Pre-, post-, and peri-operative CRP
Measured: 4 days
Pre-, post-, and peri-operative creatinine
Pre-, post-, and peri-operative creatinine
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start5 Sep 2019
- Primary completion5 Sep 2029 (estimated)
- Study completion5 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vascular Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Miler, MSc BSc Hons, Principal investigator, principle investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014647
- Sponsor's protocol ID
- 260029 (34-03-19)
- Acronym
- MOBOS
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2019
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17525578Bursi 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.
PubMed 16055493Canavan 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.
PubMed 26231089Feringa 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.
PubMed 16914484Mahla 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.
PubMed 17525582van 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.
PubMed 16979009Yeh 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.
PubMed 15997451
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
- ClinicalTrials.gov ID
- NCT04014647
- Acronym / sponsor ID
- MOBOS / 260029 (34-03-19)
- Conditions
- Vascular Surgical Procedure
- Keywords
- Vascular Surgical Procedure, Pro-brain natriuretic peptide (1-76), Natriuretic Peptide, Brain, Troponin I, Galectin 3, Biomarkers, Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 5 Sep 2029 (estimated)
- Study completion
- 5 Sep 2029 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Event-free | – | –Patients who have had no negative events (as described in group 2) |
| Negative event | – | –Group 2 - patients with one or more of the following negative events post-operatively: * Whether the patient has been prescribed inotropic support * Wound infection by assessing use of antibiotics. * Length of stay in hospital >1 week * Reduced renal function assessed by having any AKI alert during hospital stay * Cardiac event within 31 days following surgery * Death within 31 days following surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred to have vascular surgery
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Time frame: 4 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 17525578Augoustides 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.
- Background: PubMed 16055493Bursi 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.
- Background: PubMed 26231089Canavan 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.
- Background: PubMed 16914484Feringa 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.
- Background: PubMed 17525582Mahla 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.
- Background: PubMed 16979009van 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.
- Background: PubMed 15997451Yeh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Miler, MSc BSc Hons principal investigator
principle investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Surgical Procedure, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Miler, MSc BSc Hons (+44(0)1603-286-932, emma.miler@nnuh.nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP blood test measured on the day of (pre-) vascular surgery (time frame: 4 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014647, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.