An observational study in Patent Foramen Ovale, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University Health Network, Toronto · Observational
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.
134 studies on the registry are indexed under Foramen Ovale, Patent; 46 are open to participants now.
This study's planned enrollment of 408 is above the median of 226 across 57 observational studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients referred for an elective, non-cardiac, non-vascular and non-brain surgery
Exclusion Criteria:
Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO
Diagnostic Test: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) · Diagnostic Test: Transcranial Doppler (TCD) · Diagnostic Test: Transthoracic Echocardiogram (TTE)
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
Used to diagnose PFO
Used to diagnose PFO.
Prevalence 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
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto