Vascular Surgical Procedure Clinical Trial
— MOBOSOfficial title:
Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery
Verified date | December 2023 |
Source | Norfolk and Norwich University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Norfolk & Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
Julie Dawson |
United Kingdom,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04894864 -
Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
|
Phase 4 |