Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01369537
First received: June 7, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

Two hundred million adults worldwide have major surgery every year. A million of these patients will have an obvious stroke after their surgery. Another 10 million patients may have "silent" strokes. Although silent strokes are not diagnosed immediately, they are likely to reduce patients' short-term memory, concentration, and ability to function at home. However, the investigators do not know how common silent strokes are after noncardiac surgery, nor the extent to which they affect brain function.

The investigators will first perform a pilot trial to determine the feasibility of the larger study that will provide the definitive answer to this question. Participating patients will be assessed by questionnaire before and after surgery, and will have a magnetic resonance imaging (MRI) study of the brain after the surgery to look for silent strokes. Combining the results of the MRI and the questionnaires will allow us to determine the frequency of silent strokes after non-cardiac surgery, and their effect on brain function. The NeuroVISION Pilot Study will determine the feasibility of a large study to examine the frequency and the impact of silent stroke in patients who undergo noncardiac surgery.


Condition
Perioperative Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Rate of recruitment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
adults > 65 yrs undergoing noncardiac surgery

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients aged 65 years and older undergoing noncardiac surgery and staying in hospital overnight.

Criteria

Inclusion Criteria:

  • age 65,
  • undergoing noncardiac surgery,
  • regional or general anesthetic.

Exclusion Criteria:

-Patients who have a contraindication to MRI.

  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: NCT01369537

Locations
Canada, Ontario
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: PJ Devereaux, MD, PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01369537     History of Changes
Other Study ID Numbers: NeuroVISION Pilot
Study First Received: June 7, 2011
Last Updated: September 5, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 22, 2014