Condition or disease |
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Vascular Surgical Procedure |
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 |
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 |
Group/Cohort |
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Event-free
Patients who have had no negative events (as described in group 2)
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Negative event
Group 2 - patients with one or more of the following negative events post-operatively:
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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 |
Inclusion Criteria:
Exclusion Criteria:-
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 |
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 |
Principal Investigator: | Emma Miler, MSc BSc Hons | principle investigator |
Tracking Information | |||||||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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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 |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:-
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||||||
Study Sponsor | Julie Dawson | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Norfolk and Norwich University Hospitals NHS Foundation Trust | ||||||||
Verification Date | November 2019 |