NCT05592301

Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

Canadian Patent Foramen Ovale and Perioperative Stroke Evaluation Study (CAPPRES): A Feasibility Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 408 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Foramen Ovale

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)	The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
DIAGNOSTIC_TEST	Transcranial Doppler (TCD)	Used to diagnose PFO
DIAGNOSTIC_TEST	Transthoracic Echocardiogram (TTE)	Used to diagnose PFO.

Timeline

• Start date: 2023-07-07
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-10-24
• Last updated: 2023-07-17

Locations

1 site across 1 country: Canada