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

NCT01369537 | Completed

• 1 other identifier: NeuroVISION Pilot
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Stroke

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment

  2 years

Study Arms (1)

adults > 65 yrs undergoing noncardiac surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients who have a contraindication to MRI.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (1)

• 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.

  PMID: 27440630 DERIVED

Study Officials

• PJ Devereaux, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

CA (1)