Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

Recruiting

• Conditions: Patent Foramen Ovale
• Interventions: Diagnostic Test: Diffusion-weighted Magnetic Resonance Imaging (DW-MRI); Diagnostic Test: Transcranial Doppler (TCD); Diagnostic Test: Transthoracic Echocardiogram (TTE)

• Registration Number: NCT05592301
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Status Verified: 2023-07
• Study Start: 2023-07-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-17
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 408

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical patients	Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)	Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO
Surgical patients	Transthoracic Echocardiogram (TTE)	Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO
Surgical patients	Transcranial Doppler (TCD)	Patients undergoing major non-cardiac, non-vascular, and non-brain surgery who will be examined for a presence of PFO

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Toronto General Hospital, UHN; 🇨🇦 Toronto, Ontario, Canada