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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Roche Diagnostic Ltd.
Heart and Stroke Foundation of Ontario
Population Health Research Institute
Ontario Ministry of Research and Innovation
McMaster University
CLARITY Group
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00512109
First received: August 3, 2007
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition
Vascular Death
Myocardial Infarction
Cardiac Arrest
Stroke

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

Resource links provided by NLM:


Further study details as provided by McMaster University:

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., 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. ] [ 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 ]

Estimated Enrollment: 40000
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor)
São Paulo, SP, Brazil, 04005-000
Canada, Ontario
Health Science Centre, McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Saint Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
China
Prince of Wales Hospital
Hong-Kong, China
Colombia
Universidad Autónoma de Bucaramanga
Bucaramanga, Santander, Colombia
India
St. John's Medical College
Bangalore, India
Malaysia
Hospital: University Malaya
Kuala Lumpur, Malaysia, 50603
Spain
Centro Cochrane Iberoamericano. Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Roche Diagnostic Ltd.
Heart and Stroke Foundation of Ontario
Population Health Research Institute
Ontario Ministry of Research and Innovation
McMaster University
CLARITY Group
Investigators
Principal Investigator: Philip J Devereaux, MD, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier: NCT00512109     History of Changes
Other Study ID Numbers: VISIONAUG2/2007
Study First Received: August 3, 2007
Last Updated: April 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
vascular risk
perioperative
vascular events
cohort study
surgery

Additional relevant MeSH terms:
Infarction
Heart Arrest
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014