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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00512109
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Roche Diagnostic Ltd.
Heart and Stroke Foundation of Ontario
Population Health Research Institute
Ministry of Research, Innovation and Science, Ontario
Hamilton Health Sciences Corporation
CLARITY Group
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date August 3, 2007
First Posted Date August 7, 2007
Last Update Posted Date April 24, 2018
Study Start Date August 2007
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2008)
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. ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00512109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 21, 2013)
  • 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. ]
  • For our third objective (i.e., proportion of patients with perioperative myocardial infarctions 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. ]
  • 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. ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study (VISION)
Official Title Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study
Brief Summary The investigators' study has 4 primary objectives. Among patients undergoing noncardiac surgery the investigators 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.
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Vascular Death
  • Myocardial Infarction
  • Cardiac Arrest
  • Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 7, 2015)
40060
Original Estimated Enrollment
 (submitted: August 3, 2007)
40000
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Canada,   China,   Colombia,   India,   Malaysia,   Spain
Removed Location Countries Italy
 
Administrative Information
NCT Number NCT00512109
Other Study ID Numbers VISIONAUG2/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party McMaster University
Study Sponsor McMaster University
Collaborators
  • Roche Diagnostic Ltd.
  • Heart and Stroke Foundation of Ontario
  • Population Health Research Institute
  • Ministry of Research, Innovation and Science, Ontario
  • Hamilton Health Sciences Corporation
  • CLARITY Group
Investigators
Principal Investigator: Philip J Devereaux, MD, PhD McMaster University
PRS Account McMaster University
Verification Date March 2016