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Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION)

This study is currently recruiting participants.
Verified by Hamilton Health Sciences, June 2008

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
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00512109
  Purpose

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
Vascular Death
Myocardial Infarction
Cardiac Arrest
Stroke

MedlinePlus related topics:   Heart Attack   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study

Further study details as provided by Hamilton Health Sciences:

Primary Outcome Measures:
  • For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) [ Time Frame: 30 days post surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • For our second objective (i.e., the optimal clinical model to predict major perioperative vascular events) our primary and only outcome is major vascular events. [ Time Frame: 30 days after surgery. ] [ Designated as safety issue: No ]
  • For our third objective (i.e., the proportion of patients with perioperative MIs that may go undetected without perioperative troponin monitoring) our outcome is myocardial infarction that probably or possibly would have gone undetected [ Time Frame: 30 days after surgery. ] [ Designated as safety issue: No ]
  • For our fourth objective (i.e., the relationship between postoperative troponin measurements and the 1 year risk of vascular death) our outcomes are vascular death, and major vascular events (i.e., vascular death, MI, cardiac arrest, stroke) [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   40000
Study Start Date:   August 2007
Estimated Study Completion Date:   August 2010

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

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.


Criteria

Inclusion Criteria:

  • All patients who undergo noncardiac surgery are eligible if they are > 45 years of age and receive a general or regional anesthetic (i.e., plexus block, spinal, or epidural).

Exclusion Criteria:

  • We will exclude patients undergoing noncardiac surgery who do not require at least an overnight hospital admission after surgery or who only receive infiltrative (i.e., local) or topical anesthesia. We will also exclude patients previously enrolled in the VISION Study and patients who do not consent to participate.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512109

Contacts
Contact: Philip J Devereaux, MD.     905-525-9140 ext 22063     philipj@mcmaster.ca    

Locations
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            

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

Investigators
Principal Investigator:     Philip J Devereaux, MD, PhD     Hamilton Health Sciences    
  More Information


Responsible Party:   McMaster University ( Dr. P.J. Devereaux )
Study ID Numbers:   VISIONAUG2/2007
First Received:   August 3, 2007
Last Updated:   June 13, 2008
ClinicalTrials.gov Identifier:   NCT00512109
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences:
vascular risk  
perioperative  
vascular events  
cohort study  
surgery  

Study placed in the following topic categories:
Necrosis
Death
Heart Diseases
Cerebral Infarction
Myocardial Ischemia
Stroke
Vascular Diseases
Heart Arrest
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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