Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

Patent Foramen Ovale Clinical Trial

— CAPPRES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592301
• Other study ID #: 21-5671
• Secondary ID: CAPPRES
• Status: Recruiting
• Start date: July 7, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2023
• Source: University Health Network, Toronto
• Contact: Lusine Abrahamyan, MD, PhD
• Phone: 416-340-4800
• Email: lusine.abrahamyan[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

Diagnostic Test:
• Diffusion-weighted Magnetic Resonance Imaging (DW-MRI)
The Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) is used to diagnose perioperative stroke.
• Transcranial Doppler (TCD)
Used to diagnose PFO
• Transthoracic Echocardiogram (TTE)
Used to diagnose PFO.

Locations

Country	Name	City	State
Canada	Toronto General Hospital, UHN	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Peter Munk Cardiac Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Hobbes B, Akseer S, Pikula A, Huszti E, Devereaux PJ, Horlick E, Abrahamyan L. Risk of Perioperative Stroke in Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Can J Cardiol. 2022 Aug;38(8):1189-1200. doi: 10.1016/j.cjca.2022.02.026. Epub 2022 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PFO in the target (surgical) population	Identifying PFO status using TCD & TTE	Pre-operative
Primary	The incidence of perioperative stroke in patients without PFO	Identifying perioperative stroke incidence using DW-MRI	Within 30 days of surgery
Primary	Study enrollment rate	Establishing study enrollment rate and the reasons for refusals to participate	Pre-operative
Primary	Proportion of patients completing the DW-MRI test	Developing mechanisms to successfully arrange the DW-MRI within a short timeframe	2-7 days post surgery