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Silent StrokeNCT04241289

Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

An observational study of Silent Stroke and Cognitive Decline, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Silent Stroke, Cognitive Decline
How many people
66 participants
Where
1 siteCanada
Study dates
27 Mar 2017to 30 Sep 2018
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 21 years or more scheduled to undergo isolated coronary artery bypass grafting (CABG) surgery with a median sternotomy and at least one vascular risk factor.

Who may be able to join

  • Male or female ≥ 21 years old
  • Provide written informed consent
  • Scheduled to undergo isolated CABG through a median sternotomy approach
  • Have at least one of the following risk factors:
  • Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI <0.9, or previous AAA repair)
  • Cerebrovascular disease (history of stroke, TIA, or carotid stenosis >70%)
Show all 11Show fewer
  • Renal insufficiency (eGFR <60 mL/min/1.73m2)
  • Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
  • Urgent CABG (in-patient awaiting revascularization for ACS or MI)
  • Recent smoker (within the last year)
  • Left ventricular ejection fraction <35%

Who cannot join

  • Concomitant cardiac procedure with CABG Prior enrolment in this study
  • Emergency CABG surgery (immediate revascularization for hemodynamic instability)
  • Redo CABG
  • Circulatory arrest planned during the cardiac operation
  • Diagnosed dementia of any types
  • Contra-indication for DW MRI e.g. claustrophobia, unable to lie flat for the duration of the study, pacemaker or ICD in-situ, or other metal implants

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)

The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.

Read the detailed description

Delirium and cognitive decline are common following cardiac surgery and increase the burden on patients and health care resources. Covert (sub-clinical) strokes are associated with these complications. The investigators conducted a prospective cohort pilot study enrolling consecutive cardiac surgery patients to receive a post-operative brain MRI and a series of questionnaires to assess for changes in cognition, physical function and delirium. Regional cerebral oxygen saturation (rSO2) was recorded during surgery with the use of near-infrared spectroscopy (NIRS) sensors placed on the patients' forehead. The primary aim was to determine the feasibility of conducting a larger study to establish an association between covert stroke and long-term cognitive decline in cardiac surgery patients.

Keywords
covert stroke, cognitive decline, delirium, clinical stroke, CABG surgery, near infrared spectroscopy, cerebral oxygenation
Medical subject headings
Cognitive Dysfunction, Delirium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Average recruitment rate per week

    Measured: 30 days

  2. MRI completion

    Total number of patients completing the brain MRI study

    Measured: 30 days

  3. Lost to follow-up

    Proportion of patients lost to follow-up at the end of the study

    Measured: 3 months

Secondary outcomes (6)

  1. Covert stroke

    The proportion of patients experiencing covert stroke within 30 days of surgery

    Measured: 30 days

  2. Clinical stroke

    The proportion of patients experiencing clinical stroke 30 days after surgery

    Measured: 30 days

  3. Cognitive decline (MoCA)

    The proportion of patients experiencing cognitive decline 30 days after surgery using the Montreal Cognitive Assessment (MoCA).

    Measured: 30 days

  4. Cognitive decline (DSST)

    The proportion of patients experiencing cognitive decline 30 days after surgery using the Digit Symbol Substitution Test (DSST).

    Measured: 30 days

  5. Physical function

    The proportion of patients experiencing cognitive decline 30 days after surgery using the Standard Assessment of Global-activities in the Elderly (SAGE).

    Measured: 3 months

  6. Delirium

    The proportion of patients experiencing delirium between postoperative day 2 and discharge or 30 days, whichever comes first using the Confusion Assessment Method (CAM).

    Measured: day 2 to 30 day, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start27 Mar 2017
  3. Primary completion25 Jun 2018
  4. Study completion30 Sep 2018

Resources

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
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241289
Sponsor's protocol ID
NeuroVISION Cardiac Pilot
Status last verified
Mar 2023
First submitted
22 Jan 2020
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

  • NeuroVISION Investigators. Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019 Sep 21;394(10203):1022-1029. doi: 10.1016/S0140-6736(19)31795-7. Epub 2019 Aug 15.

    PubMed 31422895

  • Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.

    PubMed 31017035

  • Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

    PubMed 22762316

  • Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.

    PubMed 11172175

  • Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.

    PubMed 17582361

  • Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.

    PubMed 27980126

  • Spence J, Lamy A, Bosch J, Thabane L, Gagnon S, Power P, Browne A, Murkin J, Devereaux PJ. Feasibility of studying the association between intraoperative regional cerebral oxygen saturation and postoperative functional decline (ReFUNCTION): a pilot sub-study of NeuroVISION-Cardiac Surgery. Can J Anaesth. 2020 Nov;67(11):1497-1506. doi: 10.1007/s12630-020-01777-3. Epub 2020 Aug 6.

    PubMed 32767054

Questions about this trial

What is this clinical trial studying?

An observational study of Silent Stroke and Cognitive Decline, run by Population Health Research Institute 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 11 inclusion and 6 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 28 Mar 2023. 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?

Recruitment rate (time frame: 30 days). The study lists 3 primary outcomes in all. 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 NCT04241289, which also lists 8 linked publications.

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 28 Mar 2023.

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