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出境医 / 临床实验 / Measurement Of NT-proBNP to Predict Outcomes in Surgery (MOBOS)

Measurement Of NT-proBNP to Predict Outcomes in Surgery (MOBOS)

Study Description
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.

Condition or disease
Vascular Surgical Procedure

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. Change in NT-proBNP peri-operatively [ Time Frame: 4 days ]
    Change in NT-proBNP peri-operatively


Secondary Outcome Measures :
  1. Pre-, post-, and peri-operative troponin I [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative troponin I

  2. Pre-, post-, and peri-operative galectin-3 [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative galectin-3

  3. Pre-, post-, and peri-operative CRP [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative CRP

  4. Pre-, post-, and peri-operative creatinine [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative creatinine


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been referred to have vascular surgery
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Emma Miler, MSc BSc Hons +44(0)1603-286-932 emma.miler@nnuh.nhs.net
Contact: Allison Chipchase, Dr +44(0)1603-286-929 allison.chipchase@nnuh.nhs.net

Locations
Layout table for location information
United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Allison Chipchase, Dr    +44 1603 287945    allison/chipchase@nnuh.nhs.uk   
Contact: Emma Miler    +44 1603 286392    emma.miler@nnuh.nhs.uk   
Sponsors and Collaborators
Julie Dawson
Investigators
Layout table for investigator information
Principal Investigator: Emma Miler, MSc BSc Hons principle investigator
Tracking Information
First Submitted Date July 8, 2019
First Posted Date July 10, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date September 5, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2019)
  • Pre-, post-, and peri-operative troponin I [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative troponin I
  • Pre-, post-, and peri-operative galectin-3 [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative galectin-3
  • Pre-, post-, and peri-operative CRP [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative CRP
  • Pre-, post-, and peri-operative creatinine [ Time Frame: 4 days ]
    Pre-, post-, and peri-operative creatinine
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement Of NT-proBNP to Predict Outcomes in Surgery
Official Title Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have been referred to have vascular surgery
Condition Vascular Surgical Procedure
Intervention Not Provided
Study Groups/Cohorts
  • 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
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.
  • 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. Epub 2005 Jul 29.
  • 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.
  • 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. Epub 2006 Aug 16.
  • 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.
  • 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. Epub 2006 Aug 28.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emma Miler, MSc BSc Hons +44(0)1603-286-932 emma.miler@nnuh.nhs.net
Contact: Allison Chipchase, Dr +44(0)1603-286-929 allison.chipchase@nnuh.nhs.net
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04014647
Other Study ID Numbers 260029 (34-03-19)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
Study Sponsor Julie Dawson
Collaborators Not Provided
Investigators
Principal Investigator: Emma Miler, MSc BSc Hons principle investigator
PRS Account Norfolk and Norwich University Hospitals NHS Foundation Trust
Verification Date November 2019