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Sponsors and Collaborators: |
Hamilton Health Sciences Roche Diagnostic Ltd. Heart and Stroke Foundation of Ontario Population Health Research Institute Early Research Award, Ministry of Research and Inovation CLARITY Group |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00512109 |
Our study has 4 primary objectives. Among patients undergoing noncardiac surgery we will determine: (1) the incidence of major perioperative vascular events; (2) the optimal clinical model to predict major perioperative vascular events; (3) the proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring; and (4) the relationship between postoperative troponin measurements and the 1 year risk of vascular death.
Condition |
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Vascular Death Myocardial Infarction Cardiac Arrest Stroke |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study |
Estimated Enrollment: | 40000 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2010 |
The increase in elderly patients undergoing surgery, the change in the invasiveness of some surgical interventions, limitations in the methodology and generalizability of previous research, and the VISION Pilot Study results highlight uncertainty about the current incidence of major vascular events and the optimal clinical risk estimation model to predict these events in patients undergoing noncardiac surgery. There is promising but inconclusive preliminary evidence that troponin measurements after surgery may allow physicians to avoid missing perioperative myocardial infarctions and may predict mortality and major vascular events in the first year following surgery. These considerations provide the impetus for the large, adequately powered, multicentre, international, prospective cohort study.
We will to determine the incidence of major vascular events, the optimal clinical model to predict major perioperative vascular events, and the extent to which troponin measurements post surgery can identify myocardial infarctions that are likely to go unrecognized and predict vascular death at 1 year. We call this study the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study.
The VISION Study is a prospective cohort study of 40,000 patients who are > 45 years of age, undergoing noncardiac surgery requiring overnight hospital admission, and receiving a general or regional anesthetic. Hospitals (including both university and non-university hospitals) in several countries around the world will recruit patients, over a 2 year period. Study personnel will evaluate patients prior to surgery, follow patients throughout their hospitalization, and contact patients at 30 days and 1 year after surgery. All patients will have troponin T measured post surgery and on the first, second, and third days after surgery. Outcome adjudicators will adjudicate all major vascular events without knowledge of a patient's vascular risk factors.
We will also determine if there are associations between any preoperative or postoperative medications and major perioperative vascular events. We will also determine if there are associations between any medications started after a major perioperative vascular event and vascular mortality 1 year after surgery. We will evaluate the 1 year risk of stroke in patients who do and do not develop atrial fibrillation after surgery and if there is an association with antiplatelet or warfarin therapy. We will measure N-terminal prohormone brain natriuretic peptide (NT-proBNP) in 8,000 - 10,000 patients prior to surgery and determine if NT-proBNP is an independent predictor of major perioperative vascular events. We will determine the incidence of perioperative new acute renal failure requiring dialysis and pneumonia and develop models to predict these events.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients who undergo noncardiac surgery who are at least 45 years of age and receive a general or regional anesthetic from University and Non-University Hospitals.
Inclusion Criteria:
Exclusion Criteria:
Contact: Philip J Devereaux, MD. | 905-525-9140 ext 22063 | philipj@mcmaster.ca |
Brazil, SP | |
Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor) | Not yet recruiting |
São Paulo, SP, Brazil, 04005-000 | |
Contact: Otavio Berwanger, Dr. 55-11-3056-6611 ext 8210 otavio.berwanger@hmv.org.br | |
Principal Investigator: Otavio Berwanger | |
Canada, Ontario | |
Health Science Centre, McMaster University | Recruiting |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Principal Investigator: Philip J Devereaux, MD, PhD | |
China, N.T. | |
Prince of Wales Hospital | Recruiting |
Hong-Kong, N.T., China | |
Contact: Mathew Chan, MD. 852-263-22894 ext 2736 mtvchan@cuhk.edu.hk | |
Principal Investigator: Mathew Chan, MD. | |
Colombia, Santander | |
Universidad Autónoma de Bucaramanga | Not yet recruiting |
Bucaramanga, Santander, Colombia | |
Contact: Juan Carlos Villar, MD, MSc, PhD 577- 678 -1080 villarj@mcmaster.ca | |
Principal Investigator: Juan Carlos Villar, MD, MSc, PhD | |
Italy | |
National Cancer Institute "Regina Elena" IFO | Recruiting |
Rome, Italy, 00144 | |
Contact: Enrico Vizza, M.D., Ph.D. 39-06-5266-6974 e.vizza@ifo.it; | |
Contact: Holger Schunemann 39-06-5266-5618 schuneh@mcmaster.ca | |
Principal Investigator: Enrico Vizza, M.D., Ph.D. | |
Malaysia | |
Hospital: University Malaya | Not yet recruiting |
Kuala Lumpur, Malaysia, 50603 | |
Contact: Chew Y Wang 603-7950-2052 wangcy1836@gmail.com | |
Principal Investigator: Chew Y Wang | |
Spain | |
Centro Cochrane Iberoamericano. Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08041 | |
Contact: Pablo Alonso Coello 34-93-291-95-27 PAlonso@santpau.es | |
Contact: Gerard Urrutia 34-93-291-95-27 GUrrutia@santpau.es | |
Principal Investigator: Pablo Alonso Coello |
Principal Investigator: | Philip J Devereaux, MD, PhD | McMaster University |
Responsible Party: | McMaster University ( Dr. P.J. Devereaux ) |
Study ID Numbers: | VISIONAUG2/2007 |
Study First Received: | August 3, 2007 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00512109 |
Health Authority: | Canada: Ethics Review Committee |
vascular risk perioperative vascular events cohort study surgery |
Necrosis Death Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke |
Vascular Diseases Heart Arrest Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |