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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05592301
Study type Observational
Source University Health Network, Toronto
Contact Lusine Abrahamyan, MD, PhD
Phone 416-340-4800
Email lusine.abrahamyan@uhnresearch.ca
Status Recruiting
Phase
Start date July 7, 2023
Completion date July 1, 2025

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