VISION
Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study
|
Status:
This study is currently recruiting participants. As of May, 2010, we have recruited over 16,000 patients and will likely report first set of results within 12 months.
Purpose:
To 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.
Location(s):
Brazil, Canada, China,Columbia, Italy, Malaysia, United States, & Spain
Year Started:
2007
Design:
Observational, Cohort, Prospective.
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.
Patient Involvement:
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.
Primary Outcome:
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).
Secondary Outcome:
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.
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.
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)
|
Source of Information:
ClinicalTrials.gov
|
Web Links and Publications:
|
|
This information last updated on: 5/25/2010
Reviewed on: 05/24/2010.
|
Trials
Directories