This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.
There is emerging evidence regarding the increased risk of perioperative stroke in patients with PFO, leading to an important clinical practice question: whether PFO should be considered in the perioperative risk assessment in non-cardiac surgery patients. The evidence base, however, comes from retrospective studies with numerous limitations. Patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo PFO screening using transcranial Doppler (TCD) and transthoracic echocardiography (TTE). Patients screened PFO+ (n=102) and matched PFO- controls (n=102) will have DW-MRI between postoperative days 2 and 7. Study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. Patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.
Study Type
OBSERVATIONAL
Enrollment
408
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
Used to diagnose PFO
Used to diagnose PFO.
Toronto General Hospital, UHN
Toronto, Ontario, Canada
RECRUITINGPrevalence of PFO in the target (surgical) population
Identifying PFO status using TCD \& TTE
Time frame: Pre-operative
The incidence of perioperative stroke in patients without PFO
Identifying perioperative stroke incidence using DW-MRI
Time frame: Within 30 days of surgery
Study enrollment rate
Establishing study enrollment rate and the reasons for refusals to participate
Time frame: Pre-operative
Proportion of patients completing the DW-MRI test
Developing mechanisms to successfully arrange the DW-MRI within a short timeframe
Time frame: 2-7 days post surgery
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