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

NCT ID: NCT01369537

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perioperative Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adults > 65 yrs undergoing noncardiac surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Patients who have a contraindication to MRI.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PJ Devereaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Juravinski Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27440630 (View on PubMed)

Other Identifiers

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NeuroVISION Pilot

Identifier Type: -

Identifier Source: org_study_id