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Completed

NCT Number: NCT04241289

Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%)
  • 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%

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 27, 2020
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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