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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369537
First Posted: June 9, 2011
Last Update Posted: September 6, 2013
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.
Information provided by (Responsible Party):
McMaster University
June 7, 2011
June 9, 2011
September 6, 2013
November 2011
December 2012   (Final data collection date for primary outcome measure)
Rate of recruitment [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01369537 on ClinicalTrials.gov Archive Site
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Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study
Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients aged 65 years and older undergoing noncardiac surgery and staying in hospital overnight.
Perioperative Stroke
Not Provided
adults > 65 yrs undergoing noncardiac surgery
Mrkobrada M, Hill MD, Chan MT, Sigamani A, Cowan D, Kurz A, Sessler DI, Jacka M, Graham M, Dasgupta M, Dunlop V, Emery DJ, Gulka I, Guyatt G, Heels-Ansdell D, Murkin J, Pettit S, Sahlas DJ, Sharma M, Sharma M, Srinathan S, St John P, Tsai S, Gelb AW, O'Donnell M, Siu D, Chiu PW, Sharath V, George A, Devereaux PJ. Covert stroke after non-cardiac surgery: a prospective cohort study. Br J Anaesth. 2016 Aug;117(2):191-7. doi: 10.1093/bja/aew179.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-Patients who have a contraindication to MRI.

Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01369537
NeuroVISION Pilot
No
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McMaster University
McMaster University
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Principal Investigator: PJ Devereaux, MD, PhD McMaster University
McMaster University
September 2013