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Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

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.
 
ClinicalTrials.gov Identifier: NCT04241289
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.

Condition or disease
Silent Stroke Cognitive Decline

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.

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 30 days ]
    Average recruitment rate per week

  2. MRI completion [ Time Frame: 30 days ]
    Total number of patients completing the brain MRI study

  3. Lost to follow-up [ Time Frame: 3 months ]
    Proportion of patients lost to follow-up at the end of the study


Secondary Outcome Measures :
  1. Covert stroke [ Time Frame: 30 days ]
    The proportion of patients experiencing covert stroke within 30 days of surgery

  2. Clinical stroke [ Time Frame: 30 days ]
    The proportion of patients experiencing clinical stroke 30 days after surgery

  3. Cognitive decline (MoCA) [ Time Frame: 30 days ]
    The proportion of patients experiencing cognitive decline 30 days after surgery using the Montreal Cognitive Assessment (MoCA).

  4. Cognitive decline (DSST) [ Time Frame: 30 days ]
    The proportion of patients experiencing cognitive decline 30 days after surgery using the Digit Symbol Substitution Test (DSST).

  5. Physical function [ Time Frame: 3 months ]
    The proportion of patients experiencing cognitive decline 30 days after surgery using the Standard Assessment of Global-activities in the Elderly (SAGE).

  6. Delirium [ Time Frame: day 2 to 30 day, whichever comes first ]
    The proportion of patients experiencing delirium between postoperative day 2 and discharge or 30 days, whichever comes first using the Confusion Assessment Method (CAM).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Male or female ≥ 21 years old
  2. Provide written informed consent
  3. Scheduled to undergo isolated CABG through a median sternotomy approach
  4. Have at least one of the following risk factors:

    1. Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI <0.9, or previous AAA repair)
    2. Cerebrovascular disease (history of stroke, TIA, or carotid stenosis >70%)
    3. Renal insufficiency (eGFR <60 mL/min/1.73m2)
    4. Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
    5. Urgent CABG (in-patient awaiting revascularization for ACS or MI)
    6. Recent smoker (within the last year)
    7. Left ventricular ejection fraction <35%

Exclusion Criteria:

  1. Concomitant cardiac procedure with CABG Prior enrolment in this study
  2. Emergency CABG surgery (immediate revascularization for hemodynamic instability)
  3. Redo CABG
  4. Circulatory arrest planned during the cardiac operation
  5. Diagnosed dementia of any types
  6. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241289


Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Andre Lamy, MD Population Health Research Institute
Publications:

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT04241289    
Other Study ID Numbers: NeuroVISION Cardiac Pilot
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
covert stroke
cognitive decline
delirium
clinical stroke
CABG surgery
near infrared spectroscopy
cerebral oxygenation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders