Patent Foramen Ovale
Conditions
Keywords
Patent Foramen Ovale, Perioperative Stroke, Diffusion-weighted Magnetic Resonance Imaging
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTDiffusion-weighted Magnetic Resonance Imaging (DW-MRI)
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
DIAGNOSTIC_TESTTranscranial Doppler (TCD)
Used to diagnose PFO
DIAGNOSTIC_TESTTransthoracic Echocardiogram (TTE)
Used to diagnose PFO.
Sponsors
Peter Munk Cardiac Centre
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
1. patients 18 years and above; 2. referred for an elective, non-cardiac, non-vascular and non-brain surgery; 3. with an estimated hospital length of stay ≥2 days. We will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery.
Exclusion criteria
1. patients in need for long-term, perioperative anticoagulants; 2. those with comorbidities that potentially increase the risk of perioperative stroke; 3. contraindications to MRI; 4. unable to complete or adhere to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of PFO in the target (surgical) population | Pre-operative | Identifying PFO status using TCD & TTE |
| The incidence of perioperative stroke in patients without PFO | Within 30 days of surgery | Identifying perioperative stroke incidence using DW-MRI |
| Study enrollment rate | Pre-operative | Establishing study enrollment rate and the reasons for refusals to participate |
| Proportion of patients completing the DW-MRI test | 2-7 days post surgery | Developing mechanisms to successfully arrange the DW-MRI within a short timeframe |
Countries
Canada
Contacts
Primary ContactLusine Abrahamyan, MD, PhD
Backup ContactEric Horlick, MD
Outcome results
None listed