Perioperative StrokeNCT01369537
Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study
An observational study of Perioperative Stroke, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perioperative Stroke
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older undergoing noncardiac surgery and staying in hospital overnight.
Who may be able to join
- age 65,
- undergoing noncardiac surgery,
- regional or general anesthetic.
Who cannot join
- -Patients who have a contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Perioperative Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adults > 65 yrs undergoing noncardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PJ Devereaux, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369537
- Sponsor's protocol ID
- NeuroVISION Pilot
- Status last verified
- Sep 2013
- First submitted
- 7 Jun 2011
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27440630
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Impact of Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN Pilot Study
- ClinicalTrials.gov ID
- NCT01369537
- Acronym / sponsor ID
- NeuroVISION Pilot
- Conditions
- Perioperative Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults > 65 yrs undergoing noncardiac surgery | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older undergoing noncardiac surgery and staying in hospital overnight.
Key inclusion criteria (3 listed)
- age 65,
- undergoing noncardiac surgery,
- regional or general anesthetic.
Key exclusion criteria (1 listed)
- -Patients who have a contraindication to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of recruitment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Derived from this study: PubMed 27440630Mrkobrada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PJ Devereaux, MD, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Stroke, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01369537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.