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

Stroke Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512109
• Other study ID #: VISIONAUG2/2007
• Status: Completed
• First received: August 3, 2007
• Last updated: April 20, 2018
• Start date: August 2007
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40060
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Infarction
• Myocardial Infarction
• Stroke
• Vascular Death

Locations

Country	Name	City	State
Brazil	Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor)	São Paulo	SP
Canada	Health Science Centre, McMaster University	Hamilton	Ontario
Canada	Saint Joseph's Healthcare	Hamilton	Ontario
China	Prince of Wales Hospital	Hong-Kong
Colombia	Universidad Autónoma de Bucaramanga	Bucaramanga	Santander
India	St. John's Medical College	Bangalore
Malaysia	Hospital: University Malaya	Kuala Lumpur
Spain	Centro Cochrane Iberoamericano. Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (7)

Lead Sponsor	Collaborator
McMaster University	CLARITY Group, Hamilton Health Sciences Corporation, Heart and Stroke Foundation of Ontario, Ontario Ministry of Research and Innovation, Population Health Research Institute, Roche Diagnostic Ltd.

Countries where clinical trial is conducted

Brazil,  Canada,  China,  Colombia,  India,  Malaysia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		30 days post surgery.
Secondary	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.		30 days after surgery.
Secondary	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		30 days after surgery.
Secondary	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)		1 year after surgery.